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Review: Enteral Nutrition in Hospitalized Adults

21 Apr, 2025 | 13:23h | UTC

Introduction:
This is a summary of a new review published in the New England Journal of Medicine discussing the rationale, evidence, and practical considerations for administering enteral nutrition to hospitalized adults. The main objective is to provide guidance on identifying patients with disease-related malnutrition, initiating enteral feeding, and differentiating strategies for critically ill versus non–critically ill patients who require nutritional support.

Key Recommendations:

  1. Identify Malnutrition Early:

    • Screen all hospitalized patients for malnutrition (e.g., using the Malnutrition Screening Tool) on admission.

    • Confirm high-risk cases with a comprehensive nutrition assessment (e.g., GLIM or AAIM criteria).

  2. Optimize Oral Intake First:

    • Whenever possible, use strategies such as dietary modifications and oral nutritional supplements before initiating enteral nutrition.

    • Implement medical nutrition therapy with the goal of meeting at least 75% of estimated energy and protein requirements orally; consider EN/PN if this goal is not reached within approximately 5 days.

  3. Initiate Enteral Nutrition if Oral Intake Is Inadequate:

    • Consider enteral feeding for patients who fail to meet energy and protein goals and do not have contraindications (e.g., intestinal obstruction, severe shock, intestinal ischemia, or active gastrointestinal hemorrhage).

    • Dosing considerations differ significantly by patient population and clinical phase:

      • In critical illness (acute phase, first week), evidence suggests potential harm from early full caloric feeding or high protein doses (e.g., ≥2.2 g/kg/day), particularly in patients with shock or organ failure. A more “trophic” or hypocaloric approach (<70% of estimated energy needs) is often appropriate, especially if there is acute kidney injury or multiorgan dysfunction.

      • In contrast, for non–critically ill medical or surgical patients at risk of malnutrition, studies show that underfeeding is associated with worse outcomes, making it important to achieve closer to full nutritional requirements sooner.

  4. Select the Appropriate Route and Timing:

    • For short-term use (up to 6 weeks), place a nasoenteric tube.

    • For anticipated long-term support, consider a gastrostomy or jejunostomy tube.

    • Postpyloric feeding (duodenal or jejunal) may reduce aspiration risk in certain patients.

  5. Adjust Dose According to Clinical Phase:

    • In the ICU acute phase, avoid early full feeding; consider “trophic” or hypocaloric regimens.

    • As the patient recovers from critical illness, gradually increase caloric and protein delivery to meet estimated needs if tolerated, though exact targets remain under investigation.

    • In non–critically ill patients, aim to meet estimated requirements unless specific clinical issues necessitate lower delivery.

  6. Mitigate Complications:

    • Use continuous pump-assisted infusion, though volume-based feeding can improve goal attainment.

    • Monitor regularly for refeeding syndrome (e.g., hypophosphatemia, hypokalemia, hypomagnesemia) and correct electrolyte abnormalities.

    • Employ glucose management strategies to avoid hyperglycemia.

  7. Coordinate Interdisciplinary Care:

    • Engage dietitians, nursing staff, pharmacists, and other professionals to tailor therapy and optimize patient acceptance.

    • Involve patients in shared decision-making, particularly regarding personal values and treatment goals.

Conclusion:
These recommendations underscore enteral nutrition’s essential role in preventing and treating disease-related malnutrition. However, the direct impact on major outcomes (e.g., mortality, complications) varies by patient population, feeding strategy, and timing. In critically ill patients, especially during the first week of ICU care, lower-dose or “trophic” enteral feeding may be safer, whereas non–critically ill patients generally benefit from achieving nutritional targets more fully. Our understanding of optimal feeding approaches continues to evolve, particularly with regard to feeding dose during different phases of illness and recovery.

Reference:
Gramlich L, Guenter P. Enteral Nutrition in Hospitalized Adults. New England Journal of Medicine. 2025;392:1518-1530. DOI: https://doi.org/10.1056/NEJMra2406030

Diagnosis and Management of Eosinophilic Esophagitis: Updated ACG Clinical Guideline Summary

14 Jan, 2025 | 13:46h | UTC

Introduction: This summary highlights the updated American College of Gastroenterology (ACG) Clinical Guideline on eosinophilic esophagitis (EoE), a chronic, immune-mediated disease of the esophagus characterized by esophageal eosinophilia and clinical symptoms of esophageal dysfunction. Over the last decade, the incidence and prevalence of EoE have increased significantly. This guideline incorporates new diagnostic strategies, therapeutic advances, and monitoring practices, aiming to improve patient outcomes and minimize disease complications such as strictures, food impactions, and impaired quality of life. The document underscores the importance of assessing both the inflammatory and fibrostenotic components of EoE through endoscopy, histopathology, and symptom evaluation.

Key Recommendations:

  • Diagnosis:
    • Diagnose EoE when patients present with symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field (eos/hpf) on esophageal biopsies, after exclusion of other causes of esophageal eosinophilia.
    • Use a systematic scoring tool such as the EoE Endoscopic Reference Score (EREFS) to assess edema, rings, exudates, furrows, and strictures at every endoscopy.
    • Obtain at least six esophageal biopsies from two or more levels (e.g., distal and proximal) to minimize diagnostic miss rates; quantify peak eosinophil counts in each specimen.
  • Pharmacologic Therapy:
    1. Proton Pump Inhibitors (PPIs):
      • Consider high-dose PPIs (e.g., twice daily) as a first-line treatment option. Although originally used for acid suppression, PPIs also reduce eotaxin-3 expression and improve esophageal barrier function in EoE.
      • Maintain therapy long term in patients who respond, as discontinuation frequently leads to disease recurrence.
    2. Topical Corticosteroids (Swallowed Steroids):
      • Budesonide or fluticasone can be delivered via specially formulated suspensions/tablets or by swallowing inhaler medication.
      • Expect histologic remission rates of around 60%–70%.
      • Oral/esophageal candidiasis is the most common adverse event. Routine adrenal suppression testing is generally not necessary for short-term use.
    3. Dietary Elimination:
      • Empiric elimination diets (e.g., 2-food or 6-food elimination) help identify specific food triggers. Histologic remission rates can exceed 70%, particularly with the 6-food approach.
      • Less-restrictive diets (e.g., milk-only elimination) may be tried first (the “step-up” approach).
      • Do not rely on currently available skin prick or Ig-based tests to guide elimination diets, as these have poor predictive value for EoE triggers.
    4. Biologic Therapy:
      • Dupilumab (anti–IL-4 receptor alpha) is recommended in adolescents and adults (≥12 years, ≥40 kg) and is now approved for children as young as 1 year (≥15 kg) with moderate to severe, PPI-refractory EoE. Expect significant histologic, endoscopic, and symptom improvements in most patients, along with an overall favorable safety profile.
      • Other biologics (e.g., cendakimab, benralizumab, mepolizumab) remain under investigation; current data are insufficient for routine clinical use.
    5. Esophageal Dilation:
      • Perform endoscopic dilation to treat symptomatic strictures or narrow-caliber esophagi. Dilation reduces dysphagia promptly but does not alter the underlying inflammation.
      • Combine dilation with anti-inflammatory therapy to address the disease’s inflammatory component and help prevent recurrent stricture formation.
  • Maintenance and Monitoring:
    • Because EoE is chronic, continue effective therapy over the long term. Abrupt cessation of treatment often leads to relapses in symptoms and inflammation.
    • Evaluate treatment response by assessing symptoms, endoscopic findings (e.g., EREFS), and histopathology (peak eosinophil counts).
    • A target of <15 eos/hpf and near-normal endoscopic appearance (EREFS ≤2) is commonly used to define remission, although some patients aim for histologic normalization.
    • In children, ensure regular assessment of growth, development, and feeding behaviors. Referral to a nutritionist or feeding therapist is recommended if feeding difficulties or failure to thrive are present.

Conclusion: These updated ACG guidelines underscore the importance of a comprehensive, individualized approach to EoE that encompasses diagnosis, treatment of the inflammatory state, dilation of fibrotic strictures, and ongoing monitoring to maintain long-term remission. The introduction of biologics (particularly dupilumab) expands treatment options for patients nonresponsive to PPIs or topical steroids. Clinicians should adopt a structured assessment strategy—integrating clinical history, endoscopic scoring, and histological evaluation—to guide therapy selection, document treatment response, and prevent complications. With improved understanding of disease pathogenesis and evolving therapeutic tools, outcomes for patients with EoE are expected to continue to improve.

Reference: Dellon ES, Muir AB, Katzka DA, Shah SC, Sauer BG, Aceves SS, Furuta GT, Gonsalves N, Hirano I. ACG Clinical Guideline: Diagnosis and Management of Eosinophilic Esophagitis. The American Journal of Gastroenterology. 2025;120(1):31–59. DOI: https://doi.org/10.14309/ajg.0000000000003194

 

AGA Clinical Practice Update on Potassium-Competitive Acid Blockers for Foregut Disorders

14 Jan, 2025 | 11:20h | UTC

Introduction: This summary presents the key points of a recently published American Gastroenterological Association (AGA) Clinical Practice Update that reviews the role of potassium-competitive acid blockers (P-CABs) in managing acid-related foregut disorders. P-CABs offer a unique mechanism of action compared with proton pump inhibitors (PPIs) and histamine_2-receptor antagonists, potentially delivering more rapid and prolonged acid suppression. The aim of this review is to provide clinicians with evidence-based guidance on P-CAB use in gastroesophageal reflux disease (GERD), Helicobacter pylori (HP) infection, and peptic ulcer disease (PUD), clarifying their benefits, limitations, and potential place in therapy.

Key Recommendations:

  1. Overall Use of P-CABs: Clinicians should generally avoid using P-CABs as first-line therapy for acid-related conditions unless there is proven clinical superiority over PPIs. Factors such as higher costs, more limited availability, and less comprehensive long-term safety data often outweigh the advantages of P-CABs, particularly for milder disease.
  2. Cost-Effectiveness: Current U.S. costs for P-CABs may not justify routine first-line use, even if modest clinical benefits exist compared with double-dose PPIs. Long-term data on cost-effectiveness and safety remain limited.
  3. Nonerosive GERD: P-CABs are not recommended as initial treatment for heartburn without endoscopic findings (uninvestigated GERD) or nonerosive reflux disease. Clinicians may consider P-CABs for patients who have confirmed acid-related reflux and show inadequate response to twice-daily PPI therapy.
  4. On-Demand Therapy: Rapid onset of P-CABs suggests potential utility in on-demand regimens for patients previously responsive to acid suppression. While limited data show efficacy compared to placebo, further trials against PPIs and histamine_2-receptor antagonists are needed before making firm recommendations.
  5. Mild Erosive Esophagitis (LA Grade A/B): For Los Angeles classification (LA) grade A/B erosive esophagitis (EE), standard PPIs remain first-line treatment. P-CABs may be an option for patients whose esophagitis persists despite optimal PPI therapy, but initial evidence does not support routine, front-line use.
  6. Severe Erosive Esophagitis (LA Grade C/D): In more advanced EE, P-CABs can be considered for healing and maintenance, as some data suggest superior efficacy compared with standard-dose PPI. However, the lack of comparative trials with high-dose PPIs and the higher cost of P-CABs complicate their routine use as first-line therapy in severe disease.
  7. HP Eradication: P-CAB–based regimens for H pylori treatment often show higher or noninferior cure rates compared with PPI-based therapies, particularly in the presence of clarithromycin resistance. The more potent and prolonged acid suppression may enhance antibiotic efficacy, supporting the use of P-CABs in most patients with HP infection.
  8. Peptic Ulcer Disease Treatment and Prophylaxis: Current evidence indicates that P-CABs are noninferior to PPIs for ulcer healing and prevention of recurrent ulcers in patients requiring aspirin or nonsteroidal anti-inflammatory drugs. However, in light of their higher cost and similar clinical outcomes, P-CABs should not replace PPIs as first-line therapy unless patients fail PPI regimens.
  9. Ulcer Bleeding: Although data are preliminary, P-CABs may be useful following endoscopic hemostasis in high-risk ulcer bleeding. Their rapid and potent acid suppression suggests they could match or exceed high-dose PPI efficacy, but more robust comparative trials are needed.

Conclusion: Potassium-competitive acid blockers represent a valuable therapeutic option in selected patients who do not respond adequately to traditional PPIs or who have complex acid-related conditions (such as severe erosive esophagitis or antibiotic-resistant H pylori). While their more rapid onset of action and prolonged effect can be advantageous, the limited availability of long-term safety data, cost considerations, and lack of substantial clinical superiority over standard or double-dose PPIs in many indications currently limit widespread adoption. Further investigations are needed to establish cost-effectiveness, clarify safety profiles, and identify specific patient populations most likely to benefit from P-CABs.

Reference: Patel A, Laine L, Moayyedi P, Wu J. AGA Clinical Practice Update on Integrating Potassium-Competitive Acid Blockers Into Clinical Practice: Expert Review. Gastroenterology. 2024;167(6):1228–1238. https://doi.org/10.1053/j.gastro.2024.06.038

 

Systemic Therapy for Stage I-III Anal Squamous Cell Carcinoma: Highlights of the ASCO Guideline

6 Jan, 2025 | 09:00h | UTC

Introduction:
This summary presents the key points of the American Society of Clinical Oncology (ASCO) guideline on systemic therapy for patients with stage I-III anal squamous cell carcinoma (SCC). The guideline’s objectives are to offer evidence-based recommendations that support clinicians in selecting radiosensitizing chemotherapy, dosage regimens, treatment strategies, the use of induction chemotherapy, and the use of ongoing adjuvant chemotherapy. This guidance focuses on optimizing chemoradiation (CRT) to improve oncologic outcomes while minimizing toxicities, particularly the myelosuppression that can limit therapy tolerability. Patients who are immunosuppressed and those with comorbidities receive special consideration.

Key Recommendations:

Radiosensitizing Chemotherapy

  • Mitomycin-C (MMC) + Fluoropyrimidine: The standard radiosensitizing combination is MMC with fluorouracil (FU). Radiosensitizing means making the cancer cells more sensitive to radiation therapy. MMC with capecitabine (an oral alternative to FU) may also be offered, especially when infusion access is a concern. However, MMC is linked to higher hematologic toxicity, so its use demands vigilant monitoring.
  • Cisplatin + FU: An alternative option for radiosensitization. This combination demonstrated noninferiority to MMC + FU in the ACT-II trial. The guideline states that the preferable regimen for patients with immunosuppression is cisplatin and FU, due to the myelosuppression associated with MMC. However, this regimen is not limited to this population. Cisplatin is unsuitable for individuals with renal impairment, significant neuropathy, or hearing loss, and there is no evidence supporting carboplatin substitution.

Dose and Schedule

  • MMC + FU: Common regimens include MMC 10 mg/m^2 on days 1 and 29 (with caution on the second dose) or a single dose of 12 mg/m^2 on day 1, along with continuous-infusion FU (1,000 mg/m^2) on days 1–4 and 29–32. Clinicians should note that there is ongoing discussion about giving one versus two MMC doses, given the additional hematologic toxicity and radiation breaks often observed with two cycles.
  • MMC + Capecitabine: MMC (single or divided dose as above) plus capecitabine (825 mg/m^2 orally twice daily on radiation days) is often used in practice, although large randomized trial data are lacking.
  • Cisplatin + FU: Most commonly, cisplatin 60 mg/m^2 on days 1 and 29, with continuous-infusion FU (1,000 mg/m^2) on days 1–4 and 29–32, can be used. Weekly cisplatin regimens (20 mg/m^2 plus FU 300 mg/m^2) are another acceptable approach, though based on a lower level of evidence.

Single-Agent FU
For patients deemed unable to tolerate combination chemotherapy (e.g., poor performance status), single-agent FU with concurrent radiation may be offered.

Induction and Adjuvant Chemotherapy
No survival or disease-control benefit was observed with adding induction chemotherapy before CRT, nor with additional chemotherapy after CRT for localized anal cancer. Hence, routine use of induction or ongoing adjuvant therapy is not recommended.

Conclusion:
The guideline’s recommendations are based on moderate-quality evidence. These recommendations reinforce the longstanding role of MMC plus FU as the preferred radiosensitizing regimen for stage I-III anal SCC, with cisplatin-based or capecitabine-based options for specific patient needs. The guideline highlights that there are disparities in anal cancer incidence and outcomes, with higher rates among Black men and MSM. These disparities are further complicated by social determinants of health, such as smoking rates, HPV vaccination coverage, and access to screening and treatment. Limiting treatment toxicity—especially myelosuppression—remains critical to preserve treatment adherence and minimize breaks in radiation. Clinicians should tailor therapy to each patient’s comorbidities and performance status. Meanwhile, ongoing trials—such as ECOG-ACRIN 2165 (NCT03233711)—are investigating immunotherapy approaches for higher-risk locally advanced anal cancer, potentially informing future guideline updates.

Reference: Morris VK, Kennedy EB, Amin MA, et al. “Systemic Therapy for Stage I-III Anal Squamous Cell Carcinoma: ASCO Guideline.” Journal of Clinical Oncology. https://doi.org/10.1200/JCO-24-02120

 

AGA Clinical Practice Update on Managing Portal Vein Thrombosis in Cirrhotic Patients: Expert Review

3 Jan, 2025 | 10:00h | UTC

Introduction: This summary highlights key recommendations from an AGA expert review on portal vein thrombosis (PVT) in cirrhotic patients. PVT is common in cirrhosis, with an estimated five-year incidence of around 11%, and may worsen portal hypertension and elevate mortality. Management is challenging because of limited evidence, the potential complications of both PVT and anticoagulation, and significant heterogeneity regarding clot characteristics, host factors, and cirrhosis severity. This review presents the latest guidance on identifying clinically relevant PVT, selecting anticoagulation, and considering endovascular interventions, including TIPS (transjugular intrahepatic portosystemic shunt).

Key Recommendations:

  1. No Routine Screening: Asymptomatic patients with compensated cirrhosis do not require regular screening for PVT in the absence of suggestive clinical changes.
  2. Imaging Confirmation: When Doppler ultrasound reveals suspected PVT, contrast-enhanced CT or MRI is recommended to confirm the diagnosis, exclude malignancy, and characterize clot extent and occlusion.
  3. Hypercoagulability Testing: Extensive thrombophilia workup is not indicated unless there is family or personal history of thrombotic events, or associated laboratory abnormalities.
  4. Intestinal Ischemia Management: Patients who develop PVT with evidence of intestinal ischemia should receive prompt anticoagulation and, ideally, multidisciplinary team care involving gastroenterology, hepatology, interventional radiology, hematology, and surgery.
  5. Observation of Minor or Recent Thrombi: In cirrhotic patients without ischemia, with recent (<6 months) thrombi that are <50% occlusive, close imaging follow-up every three months is a reasonable option to track potential spontaneous clot regression.
  6. Anticoagulation for Significant PVT: Consider anticoagulation for more extensive or obstructive (>50%) recent PVT, especially if the main portal vein or mesenteric vessels are involved. Candidates for liver transplantation and those with inherited thrombophilia may derive additional benefit.
  7. Chronic Cavernous PVT: Anticoagulation is generally not advised in patients with long-standing (>6 months) complete occlusion and well-formed collateral channels.
  8. Variceal Screening: Perform endoscopic screening or ensure prophylaxis for varices. Avoid delays in initiating anticoagulation, as timeliness is essential for better recanalization outcomes.
  9. Choice of Anticoagulant: Vitamin K antagonists, low-molecular-weight heparin, and direct oral anticoagulants (DOACs) are all viable options in cirrhosis. DOACs may be appropriate in well-compensated (Child-Turcotte-Pugh class A or certain class B) cirrhosis but should be avoided in class C. Treatment selection should consider patient preferences, monitoring feasibility, and risk of bleeding.
  10. Duration of Therapy: Reassess clot status with cross-sectional imaging every three months. Continue anticoagulation for transplant-eligible individuals who show partial or complete recanalization, and consider discontinuation in nonresponders after six months if futility is evident.
  11. TIPS Revascularization: Portal vein revascularization using TIPS may be pursued in patients who have other TIPS indications (like refractory ascites or variceal bleeding) or to improve transplant feasibility by recanalizing portal flow.

Conclusion: PVT in cirrhosis remains a complex clinical issue requiring careful evaluation of clot extent, timing, and the potential need for transplantation. The recommendations presented here underscore prompt imaging, timely anticoagulation for high-risk thrombi, and individualized therapy based on Child-Turcotte-Pugh classification and bleeding risk. When necessary, multidisciplinary collaboration is key to achieving optimal patient outcomes. Prospective randomized trials and standardized classifications of PVT will be instrumental in refining future guidelines.

Reference:
Davis JPE, Lim JK, Francis FF, Ahn J. AGA Clinical Practice Update on Management of Portal Vein Thrombosis in Patients With Cirrhosis: Expert Review. Gastroenterology. 2024. DOI: http://doi.org/10.1053/j.gastro.2024.10.038

 

Meta-analysis: One-day Low-residue Diet Achieves Comparable Bowel Cleansing Compared to Multi-day Regimens

26 Dec, 2024 | 18:21h | UTC

Background: Colorectal cancer remains a leading cause of cancer-related morbidity worldwide, making early detection through colonoscopy essential. Adequate bowel preparation is crucial to maximize mucosal visibility and detect lesions effectively. Although low-residue diets (LRDs) are commonly recommended before colonoscopy, guidelines vary regarding the optimal duration (one day versus multiple days). This systematic review and meta-analysis evaluated whether a one-day LRD regimen is non-inferior to multi-day protocols in achieving satisfactory bowel cleansing and lesion detection.

Objective: To compare the efficacy of 1-day versus >1-day LRD regimens for bowel preparation in adult patients undergoing elective colonoscopy, focusing on bowel cleanliness, polyp detection, and adenoma detection rates.

Methods: A comprehensive search of PubMed, Cochrane Central Register of Controlled Trials, ScienceDirect, Scopus, and ClinicalTrials.gov was conducted for randomized controlled trials (RCTs) comparing 1-day with >1-day LRD regimens. Six RCTs involving 2,469 participants met inclusion criteria. Patients were randomized to either a 1-day LRD (n=1,237) or a multi-day LRD (n=1,232). Adequate bowel preparation was primarily defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in each segment or total BBPS ≥6. Secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), withdrawal time, cecal intubation rate, and cecal intubation time.

Results: Both groups demonstrated similar rates of adequate bowel preparation (87.2% in the 1-day LRD vs. 87.1% in the multi-day group), with no significant difference (OR=1.03, 95% CI, 0.76–1.41; p=0.84; I2=0%). PDR was likewise comparable (OR=0.91, 95% CI, 0.76–1.09; p=0.29; I2=16%), as was ADR (OR=0.87, 95% CI, 0.71–1.08; p=0.21; I2=0%). Withdrawal time did not differ (MD=–0.01 minutes, 95% CI, –0.25 to 0.24; p=0.97; I2=63%), and cecal intubation parameters were also statistically similar. Across studies, the pooled mean global BBPS revealed minimal difference (MD=0.16, 95% CI, –0.02 to 0.34; p=0.08; I2=15%), confirming the non-inferiority of a shorter LRD protocol.

Conclusions: A one-day LRD achieves bowel cleansing outcomes comparable to those of multi-day LRDs, without compromising polyp or adenoma detection. This shorter regimen may help optimize patient adherence, reduce dietary restriction burden, and simplify procedural logistics, especially for busy endoscopy practices.

Implications for Practice: Adopting a 1-day LRD can streamline preparation, improve patient satisfaction, and maintain high-quality visualization. Clinicians should weigh individual patient factors such as chronic constipation or comorbidities but may generally favor a shorter dietary restriction period to enhance compliance and comfort.

Study Strengths and Limitations: This meta-analysis included only RCTs, strengthening its internal validity. Heterogeneity for primary outcomes was minimal. However, the included trials employed varied dietary protocols and bowel preparation solutions. Additionally, some studies lacked uniform reporting of cecal intubation endpoints, limiting direct comparisons. Future investigations with standardized outcome measures could offer more definitive guidance.

Future Research: Further large-scale RCTs should assess cost-effectiveness, patient-reported outcomes, and LRD composition in specific populations. Identifying optimal dietary instructions for individuals with slower colonic transit or specific nutritional needs would refine colonoscopy preparation guidelines and potentially increase detection of precancerous lesions.

Reference: Putri RD, et al. One-day low-residue diet is equally effective as the multiple-day low-residue diet in achieving adequate bowel cleansing: a meta-analysis of randomized controlled trials. Clinical Endoscopy. 2024. DOI: https://doi.org/10.5946/ce.2024.061

 

RCT: Avoiding Prophylactic Drain Increases Postoperative Invasive Procedures After Gastrectomy

25 Dec, 2024 | 12:47h | UTC

Background: Prophylactic abdominal drainage following gastrectomy for gastric cancer has been debated for decades. While some Enhanced Recovery After Surgery (ERAS) guidelines discourage routine drains, many surgeons still advocate their use to detect and manage intra-abdominal collections before they become severe. Previous trials were small and underpowered, thus failing to provide robust evidence regarding the real need for prophylactic drains.

Objective: To determine whether omitting a prophylactic drain in gastric cancer surgery leads to a higher likelihood of postoperative invasive procedures (reoperation or percutaneous drainage) within 30 days.

Methods: In this multicenter randomized clinical trial, 404 patients from 11 Italian centers were randomly assigned to either prophylactic drain placement or no drain at the end of subtotal or total gastrectomy. Both academic and community hospitals participated. The primary composite outcome was the rate of reoperation or percutaneous drainage within 30 postoperative days, analyzed via a modified intention-to-treat approach. Secondary endpoints included overall morbidity, anastomotic leaks, length of hospital stay, and 90-day mortality. A parallel invited commentary addressed methodological and clinical perspectives.

Results: Among the 390 patients who underwent resection, 196 had a prophylactic drain and 194 did not. By postoperative day 30, 7.7% of patients in the drain group required reoperation or percutaneous drainage, compared with 15% in the no-drain group. This statistically significant difference was driven by a higher reoperation rate in patients without drains. Both groups had similar anastomotic leak rates (approximately 4% overall). However, patients without prophylactic drains had a higher in-hospital mortality (4.6% vs 0.5%) and were more likely to require escalation of care. There were few drain-related complications, indicating a low risk associated with drain placement. Length of hospital stay and readmission rates were comparable between groups.

Conclusions: Omitting prophylactic drains in gastrectomy was associated with an increased need for postoperative invasive interventions, particularly reoperations. While prior guidelines have recommended against routine drain placement, these findings challenge that stance for total and even subtotal gastrectomies. Surgeons may wish to revisit existing protocols, especially in facilities with fewer resources or lower patient volumes, given the potential reduction in reoperation risk associated with prophylactic drainage.

Implications for Practice: Clinicians should carefully balance possible benefits (earlier detection of fluid collections and reduced reoperations) against potential drawbacks of drain usage. Routine placement may be reconsidered, at least in higher-risk cases or in institutions less equipped for complex salvage procedures.

Study Strengths and Limitations: Key strengths include its robust sample size and standardized criteria for complications. Limitations involve the unblinded nature of postoperative management and the lack of drain fluid amylase measurements to guide removal protocols. Additionally, differentiating total from subtotal gastrectomies might refine selection criteria for prophylactic drainage.

Future Research: Further studies could focus on stratified risk profiles for total vs subtotal gastrectomy and on biomarkers in drain fluid to identify subgroups most likely to benefit from prophylactic drainage.

Reference:
Weindelmayer J, Mengardo V, Ascari F, et al. Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial. JAMA Surg. Published online November 27, 2024. doi: http://doi.org/10.1001/jamasurg.2024.5227

Invited Commentary: Coffey MR, Lambert KE, Strong VE. Refrain From the Drain? The ADIGE Trial Brings Gastrectomy to the Debate. JAMA Surg. Published online November 27, 2024. doi: http://doi.org/10.1001/jamasurg.2024.5228

 

AGA Clinical Practice Update on Screening and Surveillance in High-Risk US Populations for Gastric Cancer: Expert Review

25 Dec, 2024 | 11:02h | UTC

Introduction:
This American Gastroenterological Association (AGA) Clinical Practice Update provides guidance on primary and secondary prevention strategies for gastric cancer (GC) among high-risk groups in the United States. GC disproportionately affects racial and ethnic minorities, certain first-generation immigrants from countries with elevated GC incidence, and individuals with specific hereditary syndromes or family histories of GC. Given ongoing disparities in diagnosis and outcomes, this document outlines best practices for recognizing at-risk individuals, performing high-quality endoscopic screening, and establishing surveillance protocols for gastric precancerous conditions.

Key Recommendations:

  1. Identify High-Risk Groups: Consider screening among first-generation immigrants from high-incidence regions, people with a family history of GC in a first-degree relative, individuals with hereditary gastrointestinal syndromes, and patients with multiple risk factors (eg, chronic Helicobacter pylori infection, smoking, diets high in salt and processed meats).
  2. Preferred Screening Modality: Upper endoscopy is considered the best method for detecting precancerous lesions (atrophic gastritis and intestinal metaplasia) and early malignancies. It allows direct visualization of the gastric mucosa, systematic biopsy, and accurate histologic staging.
  3. High-Quality Endoscopic Examination: Essential elements include high-definition endoscopes, optimal mucosal cleansing and insufflation, adequate inspection time, systematic photodocumentation, and biopsy protocols (such as the updated Sydney System) to detect and characterize precancerous changes or early cancer.
  4. H. pylori Eradication: Opportunistic screening for H. pylori and its eradication are key adjunctive measures in preventing GC development. Family-based testing—screening adult household members of H. pylori–positive individuals—may further reduce reinfection rates and disease progression.
  5. Systematic Biopsy Protocols: When atrophic gastritis or intestinal metaplasia is suspected, obtain at least five biopsies (antrum/incisura and corpus in separate containers). Any suspicious lesion should be sampled independently.
  6. Recognition of Metaplasia and Dysplasia: Endoscopists should be trained to accurately identify visual patterns associated with gastric intestinal metaplasia (GIM) and dysplasia. Artificial intelligence may hold promise, but current data are insufficient to recommend routine use.
  7. Risk Stratification and Surveillance Intervals: Patients with confirmed GIM or dysplasia, especially those with severe or extensive metaplasia, may require follow-up endoscopy every three years. Individuals with multiple risk factors or severe metaplastic changes could benefit from shorter intervals.
  8. Management of Dysplasia and Early GC: All dysplasia should be reviewed by an expert gastrointestinal pathologist. Visible high-grade dysplasia or early GC lesions generally warrant endoscopic submucosal dissection (ESD) at specialized centers to achieve en bloc, R0 resection and enable accurate pathology.
  9. Post-Resection Surveillance: Individuals with successfully resected dysplasia or early cancer need ongoing endoscopic surveillance to detect metachronous lesions. Surveillance intervals vary depending on pathology results and patient-level factors.
  10. De-Escalation of Screening: Discontinue screening or surveillance when the patient is no longer fit for potential endoscopic or surgical treatment.
  11. Equity and Sustainability: To reduce GC mortality, it is crucial to address modifiable risk factors, enhance patient access to endoscopy and skilled practitioners, and integrate research advances, especially in noninvasive biomarker development and improved endoscopic technologies.

Conclusion:
An effective US-based GC screening and surveillance program requires robust preprocedural identification of high-risk individuals, intraprocedural adherence to quality endoscopy standards, and consistent postprocedural follow-up to ensure equitable access to treatment. By refining these clinical practices and prioritizing research, meaningful reductions in GC incidence and mortality can be achieved, ultimately improving patient outcomes and addressing healthcare disparities.

Reference:
Shah SC, Wang AY, Wallace MB, Hwang JH. AGA Clinical Practice Update on Screening and Surveillance in Individuals at Increased Risk for Gastric Cancer in the United States: Expert Review. Gastroenterology. Published online December 23, 2024.
https://doi.org/10.1053/j.gastro.2024.11.001

 

RCT: Nivolumab Plus Ipilimumab Extends Progression-Free Survival in MSI-H or dMMR Metastatic Colorectal Cancer

4 Dec, 2024 | 11:51h | UTC

Background: Patients with microsatellite-instability–high (MSI-H) or mismatch-repair–deficient (dMMR) metastatic colorectal cancer typically experience poor outcomes with standard chemotherapy. Previous nonrandomized studies suggested that combining nivolumab with ipilimumab may offer clinical benefits in this population.

Objective: To evaluate the efficacy and safety of nivolumab plus ipilimumab compared with chemotherapy in patients with MSI-H or dMMR metastatic colorectal cancer who had not received prior systemic treatment for metastatic disease.

Methods: In this phase 3, open-label, randomized trial, 303 patients with unresectable or metastatic MSI-H or dMMR colorectal cancer were assigned in a 2:2:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies. The primary endpoint assessed in this interim analysis was progression-free survival (PFS) of nivolumab plus ipilimumab versus chemotherapy in patients with centrally confirmed MSI-H or dMMR status.

Results: At a median follow-up of 31.5 months, nivolumab plus ipilimumab significantly improved PFS compared to chemotherapy (P<0.001). The 24-month PFS was 72% (95% CI, 64–79) with nivolumab plus ipilimumab versus 14% (95% CI, 6–25) with chemotherapy. The restricted mean survival time at 24 months was 10.6 months longer with the combination therapy. Grade 3 or 4 treatment-related adverse events occurred in 23% of patients receiving nivolumab plus ipilimumab and 48% of those receiving chemotherapy.

Conclusions: First-line treatment with nivolumab plus ipilimumab significantly prolonged progression-free survival compared to chemotherapy in patients with MSI-H or dMMR metastatic colorectal cancer, with a lower incidence of high-grade treatment-related adverse events.

Implications for Practice: The combination of nivolumab and ipilimumab may represent a new standard of care for first-line treatment in MSI-H or dMMR metastatic colorectal cancer. However, clinicians should weigh the benefits against potential immune-related adverse events, and long-term survival benefits remain to be fully established.

Study Strengths and Limitations: Strengths include the randomized, phase 3 design and central confirmation of MSI-H or dMMR status. Limitations involve the open-label design, potential bias in patient-reported outcomes, underrepresentation of certain populations, and immature overall survival data.

Future Research: Further studies are needed to compare nivolumab plus ipilimumab directly with nivolumab monotherapy and to assess long-term overall survival benefits and quality of life in diverse patient populations.

Reference: Andre T, et al. Nivolumab plus Ipilimumab in Microsatellite-Instability–High Metastatic Colorectal Cancer. New England Journal of Medicine. 2024;391(21):2014–2026. DOI: http://doi.org/10.1056/NEJMoa2402141

 

Cohort Study: High Rate of Preventable Adverse Events in Surgical Inpatients

16 Nov, 2024 | 17:29h | UTC

Background: Adverse events during hospital admissions, particularly in surgical settings, remain a significant cause of patient harm despite efforts to improve patient safety since the “To Err is Human” report. Advances in surgical techniques and patient care necessitate an updated assessment of the current state of perioperative safety.

Objective: To estimate the frequency, severity, and preventability of adverse events associated with perioperative care in surgical inpatients and to identify the settings and healthcare professionals involved.

Methods: A multicenter retrospective cohort study was conducted across 11 US hospitals in Massachusetts. A weighted random sample of 1,009 patients was selected from 64,121 adults admitted for surgery in 2018. Trained nurses reviewed electronic health records to identify adverse events, which were then adjudicated by physicians. Adverse events were classified by type, severity, preventability, setting, and professions involved.

Results: Adverse events occurred in 38.0% of patients (95% CI, 32.6–43.4%), with major adverse events in 15.9% (12.7–19.0%). Among 593 adverse events identified, 59.5% were potentially preventable, and 20.7% were definitely or probably preventable. The most common events were surgery-related (49.3%), adverse drug events (26.6%), healthcare-associated infections (12.4%), and patient care events (11.2%). Adverse events most frequently occurred in general care units (48.8%) and involved attending physicians (89.5%) and nurses (58.9%).

Conclusions: More than one-third of surgical inpatients experienced adverse events, with nearly half classified as major and most potentially preventable. These findings highlight the critical need for ongoing improvement in patient safety throughout perioperative care involving all healthcare professionals.

Implications for Practice: Healthcare providers should enhance patient safety protocols across all perioperative settings, not just in operating rooms. Emphasis should be placed on preventing surgery-related complications, adverse drug events, and healthcare-associated infections by fostering teamwork and continuous monitoring.

Study Strengths and Limitations: Strengths include a comprehensive review of medical records and systematic classification of adverse events by trained professionals. Limitations involve the study’s confinement to Massachusetts hospitals in 2018, potential variability in documentation practices, and limited sample size affecting generalizability and specialty-specific estimates.

Future Research: Further studies are needed to assess adverse event rates in diverse geographic locations and healthcare systems, explore effective interventions to reduce preventable harm, and evaluate long-term trends in surgical patient safety.

Reference: Duclos A, Frits ML, Iannaccone C, Lipsitz SR, Cooper Z, Weissman JS, Bates DW. Safety of inpatient care in surgical settings: cohort study. BMJ. 2024; DOI: http://doi.org/10.1136/bmj-2024-080480

 

Multisociety Guidelines for Perioperative Management of GLP-1 Receptor Agonists

3 Nov, 2024 | 14:27h | UTC

Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have transformed the management of metabolic diseases such as type 2 diabetes, obesity, and heart failure by enhancing glycemic control and promoting satiety. However, their effect of delaying gastric emptying has raised perioperative safety concerns due to the risk of residual gastric contents leading to pulmonary aspiration during anesthesia. Reports of aspiration incidents and gastrointestinal side effects like nausea and vomiting have prompted the need for unified clinical guidance. This multisociety clinical practice guideline aims to provide recommendations for safely managing patients on GLP-1RAs during the perioperative period, balancing metabolic benefits with procedural risks.

Key Recommendations:

  1. Shared Decision-Making:
    • Collaborative Approach: The continuation or discontinuation of GLP-1RAs should involve shared decision-making among the patient, surgical team, anesthesia providers, and prescribing clinicians.
    • Risk Assessment: Evaluate factors that elevate the risk of delayed gastric emptying and aspiration, including:
      • Dose Escalation Phase: Higher risk during dose escalation compared to maintenance.
      • Higher Dosage: Increased gastrointestinal side effects with higher doses.
      • Weekly Formulations: Greater side effects with weekly dosing compared to daily formulations.
      • Gastrointestinal Symptoms: Presence of nausea, vomiting, abdominal pain, dyspepsia, or constipation.
      • Comorbid Conditions: Conditions like gastroparesis, bowel dysmotility, or neurological disorders affecting gastric motility.
    • Timing: Conduct risk assessments well in advance of surgery to allow for appropriate preoperative planning.
  2. Management of GLP-1RA Therapy:
    • Continuation in Low-Risk Patients: GLP-1RAs may be continued preoperatively in patients without elevated risk factors.
    • Balancing Risks in High-Risk Patients:
      • Metabolic vs. Procedural Risks: Weigh the risks of aspiration against potential metabolic complications like hyperglycemia if GLP-1RAs are withheld.
      • Avoiding Bias: Decisions should not be based solely on obesity status to prevent bias.
    • Discontinuation Guidelines:
      • Daily Formulations: Hold on the day of surgery.
      • Weekly Formulations: Discontinue one week prior to surgery.
    • Day-of-Surgery Assessment: All patients should be evaluated for symptoms of delayed gastric emptying on the day of the procedure, regardless of GLP-1RA usage.
  3. Minimizing Aspiration Risk:
    • Preoperative Dietary Modifications:
      • Liquid Diet: Implement a liquid diet for at least 24 hours before surgery, similar to protocols for colonoscopy and bariatric procedures.
    • Gastric Content Assessment:
      • Point-of-Care Ultrasound: Use gastric ultrasound to assess residual gastric contents when there is concern for delayed emptying, acknowledging potential limitations in resources and expertise.
    • Anesthesia Plan Adjustments:
      • Rapid Sequence Induction: Consider rapid sequence induction with tracheal intubation to minimize aspiration risk in patients with confirmed or suspected delayed gastric emptying.
      • Procedure Continuation vs. Cancellation: Engage in shared decision-making to weigh the benefits of proceeding with the procedure against the risks, aiming to avoid unnecessary cancellations.

Conclusion: By adopting these recommendations, healthcare providers can enhance patient safety during the perioperative period for those receiving GLP-1RA therapy. The guidelines emphasize individualized care through shared decision-making, considering both metabolic benefits and procedural risks. Implementing these practices is expected to reduce aspiration incidents, optimize surgical outcomes, and ensure equitable care without bias against patients with obesity or metabolic disorders. As new evidence and medications emerge, these guidelines may be updated to reflect best practices.

Reference: Kindel TL, Wang AY, Wadhwa A, et al. Multisociety clinical practice guidance for the safe use of glucagon-like peptide-1 receptor agonists in the perioperative period. Surgery for Obesity and Related Diseases. 2024; In Press. https://doi.org/10.1016/j.soard.2024.08.033

 

RCT: Low-Dose Amitriptyline Effective as Second-Line Treatment for Irritable Bowel Syndrome

20 Oct, 2024 | 15:56h | UTC

Background: Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies—such as dietary changes and antispasmodic drugs—are ineffective, the UK National Institute for Health and Care Excellence (NICE) recommends considering low-dose tricyclic antidepressants as second-line treatment. However, their effectiveness in primary care is uncertain, and they are infrequently prescribed in this setting.

Objective: To determine whether titrated low-dose amitriptyline is effective as a second-line treatment for IBS in primary care.

Methods: In a randomized, double-blind, placebo-controlled, phase 3 trial (ATLANTIS) conducted at 55 general practices in England, 463 adults aged 18 years or older with Rome IV IBS and ongoing symptoms despite first-line therapies were randomized 1:1 to receive low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months. Dose titration over 3 weeks up to 30 mg once daily was allowed according to symptoms and tolerability. The primary outcome was the IBS Severity Scoring System (IBS-SSS) score at 6 months. Secondary outcomes included subjective global assessment (SGA) of relief of IBS symptoms, adequate relief for at least 50% of weeks, and adverse events.

Results: Among 463 participants (mean age 48.5 years; 68% female), low-dose amitriptyline was superior to placebo at 6 months, with a significant mean difference in IBS-SSS score between groups (–27.0; 95% CI, –46.9 to –7.1; P = .0079). More participants reported relief of IBS symptoms with amitriptyline compared to placebo (61% vs 45%; odds ratio [OR] 1.78; 95% CI, 1.19–2.66; P = .0050). Adequate relief of IBS symptoms for at least 50% of weeks was higher with amitriptyline (41% vs 30%; OR 1.56; 95% CI, 1.20–2.03; P = .0008). Adverse events were more frequent with amitriptyline, mainly related to anticholinergic effects such as dry mouth (54%) and drowsiness (53%), but most were mild. Withdrawals due to adverse events were slightly higher with amitriptyline (13% vs 9%).

Conclusions: Low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care and was safe and well tolerated.

Implications for Practice: General practitioners should consider prescribing low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, providing appropriate support for patient-led dose titration.

Study Strengths and Limitations: Strengths include the large sample size, primary care setting, and extended treatment duration. Limitations involve underrepresentation of patients with IBS with constipation, potential unblinding due to side effects, and a predominantly White participant population.

Future Research: Further trials assessing amitriptyline as a first-line therapy for IBS in primary care and studies on long-term outcomes are recommended.

Reference: Ford AC, Wright-Hughes A, Alderson SL, et al. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in Primary Care (ATLANTIS): a Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial. Lancet. 2023; DOI: http://doi.org/10.1016/S0140-6736(23)01523-4

 

RCT: Milk Elimination Diet Comparable to Four-Food Elimination in Pediatric EoE

20 Oct, 2024 | 15:04h | UTC

Background: Eosinophilic esophagitis (EoE) is a chronic immune-mediated condition characterized by eosinophil infiltration of the esophageal mucosa, leading to symptoms such as nausea, vomiting, abdominal pain, and dysphagia in children. While elimination of six common food allergens is effective, this approach is highly restrictive and may adversely affect quality of life (QoL). Less restrictive diets could potentially balance efficacy with improved QoL.

Objective: To compare the efficacy of a one-food elimination diet excluding milk (1FED) versus a four-food elimination diet excluding milk, egg, wheat, and soy (4FED) in treating pediatric EoE.

Methods: In this multicenter, randomized, nonblinded trial conducted at ten sites in the United States, 63 children aged 6 to 17 years with histologically active and symptomatic EoE were randomized 1:1 to either 1FED (n = 38) or 4FED (n = 25) for 12 weeks. The primary endpoint was symptom improvement measured by the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS). Secondary endpoints included the proportion achieving histologic remission (<15 eosinophils per high-power field), changes in histologic features (histology scoring system), endoscopic severity (endoscopic reference score), transcriptome profiling (EoE diagnostic panel), QoL scores, and predictors of remission.

Results: Out of 63 participants, 51 completed the study (1FED, n = 34; 4FED, n = 17). The 4FED group showed a greater improvement in mean PEESS scores compared to the 1FED group (−25.0 vs. −14.5; P = .04). However, histologic remission rates were similar between 4FED and 1FED (41% vs. 44%; P = 1.00). Changes in the histology scoring system (−0.25 vs. −0.29; P = .77), endoscopic reference score (−1.10 vs. −0.58; P = .47), and QoL scores were comparable between groups. The withdrawal rate was higher in the 4FED group compared to the 1FED group (32% vs. 11%; P = .0496).

Conclusions: While the 4FED moderately improved symptoms more than the 1FED, both diets resulted in similar histologic, endoscopic, QoL, and transcriptomic outcomes. Given its comparable effectiveness, better tolerability, and simplicity, the 1FED is a reasonable first-choice therapy for pediatric EoE.

Implications for Practice: Eliminating cow’s milk alone may be preferable as initial dietary therapy for children with EoE due to its simplicity and similar efficacy compared to more restrictive diets. Clinicians should consider starting with a milk elimination diet before progressing to more restrictive elimination diets if necessary.

Study Strengths and Limitations: Strengths of the study include its randomized, multicenter design; standardized treatment instructions; and use of validated symptom and QoL instruments. Limitations include early termination due to low enrollment, a higher withdrawal rate in the 4FED group, nonblinded interventions, and potential bias from participant expectations.

Future Research: Further large-scale, randomized studies are needed to confirm these findings and to identify biomarkers that predict response to dietary therapy in pediatric EoE.

Reference: Kliewer KL, Abonia JP, Aceves SS, et al. (2024) One-food versus 4-food elimination diet for pediatric eosinophilic esophagitis: A multisite randomized trial. Journal of Allergy and Clinical Immunology. DOI: http://doi.org/10.1016/j.jaci.2024.08.023

 

RCT: H. pylori Screening Added to Fecal Immunochemical Testing Did Not Reduce Gastric Cancer Incidence or Mortality

4 Oct, 2024 | 11:00h | UTC

Background: Gastric cancer is a leading cause of cancer-related mortality worldwide, particularly in East Asia. Helicobacter pylori infection is a well-established risk factor for gastric cancer development. While eradication therapy may prevent gastric cancer, the effectiveness of community-based H. pylori screening on gastric cancer incidence and mortality remains uncertain.

Objective: To determine whether adding H. pylori stool antigen (HPSA) testing to fecal immunochemical test (FIT) screening reduces gastric cancer incidence and mortality compared to FIT screening alone.

Methods: In a pragmatic randomized clinical trial conducted in Changhua County, Taiwan (2014–2018), 152,503 residents aged 50 to 69 years eligible for biennial FIT screening were randomized to receive an invitation for HPSA testing plus FIT (n = 63,508) or FIT alone (n = 88,995). Participants in the HPSA + FIT group with positive HPSA results were offered antibiotic eradication therapy. Primary outcomes were gastric cancer incidence and mortality, assessed via national cancer and death registries.

Results: Participation rates were higher in the HPSA + FIT group (49.6%) than in the FIT-alone group (35.7%). In the HPSA + FIT group, 38.5% tested positive for HPSA, and 71.4% of these received antibiotic treatment, achieving a 91.9% eradication rate. Over a median follow-up of approximately 5 years, gastric cancer incidence did not differ significantly between the HPSA + FIT and FIT-alone groups (0.032% vs 0.037%; mean difference –0.005%; 95% CI, –0.013% to 0.003%; P = .23). Gastric cancer mortality rates were also similar (0.015% vs 0.013%; mean difference 0.002%; 95% CI, –0.004% to 0.007%; P = .57). Adjusted analyses accounting for participation rates, follow-up duration, and baseline characteristics showed a lower gastric cancer incidence in the HPSA + FIT group (RR 0.79; 95% CI, 0.63–0.98; P = .04), but no difference in mortality (RR 1.02; 95% CI, 0.73–1.40; P = .91). Adverse effects from antibiotics were mild, with abdominal pain or diarrhea occurring in 2.1%.

Conclusions: An invitation to HPSA testing combined with FIT did not significantly reduce gastric cancer incidence or mortality compared to FIT alone over a median follow-up of about 5 years. Adjusted analyses suggest a potential reduction in gastric cancer incidence but not mortality when accounting for participation rates and follow-up duration.

Implications for Practice: Adding H. pylori screening to existing FIT programs may not significantly reduce gastric cancer incidence or mortality in the short term, possibly due to low participation rates, incomplete eradication, and limited follow-up. Clinicians should consider these factors when implementing community-based H. pylori screening and weigh the benefits against resource utilization and patient adherence.

Study Strengths and Limitations: Strengths include a large sample size and integration of HPSA testing into an existing FIT screening infrastructure. Limitations encompass differences in participation rates and baseline characteristics between groups, a relatively short follow-up period, and only 71.4% of HPSA-positive participants receiving eradication therapy, which may have reduced the ability to detect significant effects.

Future Research: Longer-term studies with higher participation and eradication rates are needed to assess the long-term benefits of H. pylori screening on gastric cancer incidence and mortality. Research should explore strategies to improve screening uptake and treatment adherence.

Reference: Lee Y-C, et al. (2024) Screening for Helicobacter pylori to Prevent Gastric Cancer: A Pragmatic Randomized Clinical Trial. JAMA. DOI: http://doi.org/10.1001/jama.2024.14887

 

Summary: Perioperative Management of Patients Taking Direct Oral Anticoagulants

19 Sep, 2024 | 21:12h | UTC

Direct oral anticoagulants (DOACs)—including apixaban, rivaroxaban, edoxaban, and dabigatran—are increasingly used for stroke prevention in atrial fibrillation and for treating venous thromboembolism. Effective perioperative management of DOACs is essential to minimize bleeding and thromboembolic risks during surgical and nonsurgical procedures. Below are practical recommendations focused on the perioperative management of patients taking DOACs, based on a recent JAMA review article.

Elective Surgical or Nonsurgical Procedures

Classify Bleeding Risk of Procedures:

  1. Minimal Risk:
    • Minor dental procedures (e.g., cleaning, extractions)
    • Minor dermatologic procedures (e.g., skin lesion removal)
    • Cataract surgery
  2. Low to Moderate Risk:
    • Endoscopic procedures without high-risk interventions
    • Cholecystectomy
    • Inguinal hernia repair
  3. High Risk:
    • Major surgery (e.g., cancer surgery, joint replacement)
    • Procedures involving neuraxial anesthesia
    • Endoscopic procedures with high-risk interventions (e.g., large polyp removal)

DOAC Management Strategies:

  1. Minimal Bleeding Risk Procedures:
    • Option 1: Continue DOACs without interruption.
    • Option 2: For added safety, withhold the morning dose on the day of the procedure (especially for twice-daily DOACs like apixaban and dabigatran).
  2. Low to Moderate Bleeding Risk Procedures:
    • Preoperative:
      • Discontinue DOACs 1 day before the procedure.
      • This allows approximately 2 half-lives for drug clearance.
    • Postoperative:
      • Resume DOACs 1 day after the procedure, ensuring adequate hemostasis.
  3. High Bleeding Risk Procedures:
    • Preoperative:
      • Discontinue DOACs 2 days before the procedure.
      • This allows approximately 4-5 half-lives for drug clearance.
    • Postoperative:
      • Resume DOACs 2-3 days after the procedure, based on bleeding risk and hemostasis.

Evidence Supporting These Strategies:

  • The PAUSE study demonstrated that standardized interruption protocols without heparin bridging result in low rates of:
    • Thromboembolism: 0.2%–0.4%
    • Major Bleeding: 1%–2%

Postoperative DOAC Resumption:

  • Assess surgical-site hemostasis before resuming DOACs.
  • Delay resumption if there is ongoing bleeding or concerns about hemostasis.
  • For high bleeding risk procedures, consider a longer delay (2–3 days).

Perioperative Heparin Bridging:

  • Not recommended for patients on DOACs.
  • Bridging increases bleeding risk without reducing thromboembolism.
  • DOACs have rapid offset and onset, making bridging unnecessary.

Special Considerations

Patients with Impaired Renal Function:

  • For CrCl 30–50 mL/min:
    • Dabigatran: Extend preoperative discontinuation by an additional day.
  • For CrCl <30 mL/min:
    • Dabigatran is contraindicated.
    • For other DOACs, consider extending discontinuation to 3–4 days before surgery.

Patients Undergoing Neuraxial Anesthesia:

  • Discontinue DOACs for 3 days (apixaban, edoxaban, rivaroxaban) or 4 days (dabigatran) before the procedure.
  • Minimizes risk of spinal or epidural hematoma.

Dental Procedures:

  • Generally safe to continue DOACs.
  • For added safety:
    • Omit or delay the dose on the day of the procedure.
    • Employ local hemostatic measures (e.g., tranexamic acid mouthwash).

Endoscopic Procedures:

  • Low-risk procedures (e.g., diagnostic endoscopy without biopsy):
    • Follow standard DOAC interruption for low to moderate bleeding risk.
  • High-risk procedures (e.g., polypectomy of large polyps):
    • Extend DOAC discontinuation by an additional day pre- and post-procedure.

Patients Unable to Resume Oral Medications Postoperatively:

  • Use prophylactic low-molecular-weight heparin (LMWH) until oral intake is possible.
  • Avoid therapeutic-dose LMWH due to bleeding risk.

Emergent, Urgent, or Semiurgent Procedures

Risks:

  • Higher bleeding risk: Up to 23%
  • Thromboembolism risk: Up to 11%

Management Strategies:

  1. Assess Time Since Last DOAC Dose:
    • If within 48 hours, consider that significant anticoagulant effect may persist.
  2. Laboratory Testing (if available):
    • DOAC Level Testing:
      • ≥50 ng/mL: Consider using reversal agents.
      • <50 ng/mL: May proceed without reversal agents.
  3. Use of Reversal Agents:
    • For Dabigatran:
      • Idarucizumab (5 g IV)
    • For Factor Xa Inhibitors (apixaban, rivaroxaban, edoxaban):
      • Andexanet alfa (dosing based on last dose timing and amount)
      • Prothrombin Complex Concentrates (PCCs): If andexanet alfa is unavailable or contraindicated.
  4. Proceeding Without Testing:
    • If testing is unavailable and last DOAC dose was within 48 hours, consider reversal agents.
    • If >48 hours since last dose, may proceed without reversal.

Considerations:

  • Reversal agents are expensive and may carry thrombotic risks.
  • Use should be judicious, weighing risks and benefits.
  • Consult hematology or thrombosis experts when possible.

Key Takeaways

  • Elective Procedures:
    • Utilize standardized protocols based on procedural bleeding risk.
    • Routine preoperative DOAC level testing is unnecessary.
    • Avoid heparin bridging.
  • Emergent/Urgent Procedures:
    • Reversal agents may be appropriate when significant DOAC levels are present.
    • Decision to use reversal agents should consider bleeding risk, time since last dose, and availability of DOAC level testing.
  • Patient Communication:
    • Ensure patients understand the plan for DOAC interruption and resumption.
    • Provide clear instructions regarding timing and dosing.
  • Interdisciplinary Coordination:
    • Collaborate with surgical teams, anesthesiologists, and pharmacists.
    • Use electronic medical records and clinical decision support tools to enhance communication.

Conclusion

By applying standardized perioperative management protocols, clinicians can effectively balance the risks of bleeding and thromboembolism in patients taking DOACs who require surgical or nonsurgical procedures. These strategies simplify decision-making, avoid unnecessary interventions like heparin bridging, and promote patient safety.

Reference: Douketis JD, Spyropoulos AC. Perioperative Management of Patients Taking Direct Oral Anticoagulants: A Review. JAMA. 2024;332(10):825–834. doi:10.1001/jama.2024.12708

 

RCT: Cabozantinib Improves Progression-Free Survival in Advanced Neuroendocrine Tumors

17 Sep, 2024 | 11:03h | UTC

Background: Advanced neuroendocrine tumors (NETs) present limited treatment options, with many patients experiencing disease progression despite existing therapies. Angiogenesis is pivotal in NET pathogenesis. Cabozantinib, an oral tyrosine kinase inhibitor targeting VEGF receptors, MET, AXL, and RET, has demonstrated clinical activity in phase 2 studies involving NETs. The efficacy of cabozantinib in patients with progressive, advanced extrapancreatic or pancreatic NETs after prior treatments remains uncertain.

Objective: To assess the efficacy and safety of cabozantinib compared with placebo in patients with previously treated, progressive advanced extrapancreatic or pancreatic NETs.

Methods: A multicenter, double-blind, randomized, placebo-controlled phase 3 trial (CABINET) was conducted at 62 sites in the United States from October 2018 to August 2023. Eligible patients were adults aged ≥18 years with histologically confirmed, locally advanced or metastatic well- or moderately differentiated extrapancreatic or pancreatic NETs (WHO grades 1–3) and documented disease progression within 12 months prior to enrollment. Patients were randomized 2:1 to receive cabozantinib (60 mg orally once daily) or placebo. Randomization was stratified by concurrent somatostatin analogue use and primary tumor site. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review according to RECIST 1.1 criteria. Key secondary endpoints included objective response rate (ORR), overall survival (OS), and safety.

Results: A total of 203 patients with extrapancreatic NETs and 95 patients with pancreatic NETs were randomized.

  • Extrapancreatic NET Cohort:
    • Median PFS was 8.4 months with cabozantinib vs. 3.9 months with placebo (stratified hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.25–0.59; P<0.001).
    • Partial responses were observed in 5% of patients receiving cabozantinib vs. 0% with placebo.
  • Pancreatic NET Cohort:
    • Median PFS was 13.8 months with cabozantinib vs. 4.4 months with placebo (stratified HR, 0.23; 95% CI, 0.12–0.42; P<0.001).
    • Partial responses were observed in 19% of patients receiving cabozantinib vs. 0% with placebo.

Grade ≥3 treatment-related adverse events occurred in 62–65% of patients receiving cabozantinib and 23–27% receiving placebo. Common grade ≥3 adverse events included hypertension (21–22%), fatigue (11–13%), diarrhea (11%), and thromboembolic events (11%).

Conclusions: Cabozantinib significantly improved progression-free survival compared to placebo in patients with previously treated, progressive advanced extrapancreatic or pancreatic NETs. The safety profile was consistent with known adverse events associated with cabozantinib.

Implications for Practice:

  • New Treatment Option: Cabozantinib offers a new therapeutic avenue for patients with advanced NETs who have progressed after prior therapies.
  • Broad Applicability: The findings support the use of cabozantinib in both extrapancreatic and pancreatic NETs.
  • Adverse Event Management: Clinicians should closely monitor and manage treatment-related adverse events to optimize patient outcomes.

Study Strengths and Limitations: Strengths include a large sample size, randomized controlled design, and inclusion of patients who had progressed after standard therapies, enhancing the applicability of the findings to clinical practice. Limitations involve early trial termination based on interim analysis, which may overestimate the treatment effect, the use of placebo rather than an active comparator, and the high rate of dose modifications due to adverse events.

Future Research: Further studies should explore the optimal sequencing of cabozantinib with other therapies in NETs and investigate combination treatments. Long-term studies assessing overall survival benefits and quality of life are warranted.

Reference: Chan JA, Geyer S, Zemla T, et al. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors. N Engl J Med. Published online September 16, 2024. doi:10.1056/NEJMoa2400702

 

RCT: Comparing Perioperative Chemotherapy Alone to Perioperative Chemotherapy Plus Preoperative Chemoradiotherapy in Resectable Gastric Cancer

14 Sep, 2024 | 18:23h | UTC

Background:

In the management of resectable gastric cancer, perioperative chemotherapy—chemotherapy administered both before (neoadjuvant) and after (adjuvant) surgery—is the standard of care in many Western countries. This approach is based on trials like MAGIC and FLOT4-AIO, which demonstrated improved survival with perioperative chemotherapy compared to surgery alone.

Preoperative chemoradiotherapy (the combination of chemotherapy and radiotherapy before surgery) has shown benefits in other gastrointestinal cancers, such as esophageal cancer, by downstaging tumors and potentially improving surgical outcomes. However, its efficacy in gastric cancer, especially when added to perioperative chemotherapy, has not been well-established.

Objective:

To determine whether adding preoperative chemoradiotherapy to standard perioperative chemotherapy improves overall survival compared to perioperative chemotherapy alone in patients with resectable gastric and gastroesophageal junction adenocarcinoma.

Methods:

  • Study Design: International, phase 3, randomized controlled trial (TOPGEAR).
  • Participants: 574 patients with resectable adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III), clinical stage T3 or T4, and considered suitable for curative surgery.
  • Interventions:

    1. Perioperative Chemotherapy Group (Control Group):

    • Definition of Perioperative Chemotherapy: Chemotherapy administered both before (preoperative/neoadjuvant) and after (postoperative/adjuvant) surgery.
    • Chemotherapy Regimens:
      • Before 2017: Patients received three cycles before surgery and three cycles after surgery of either:
        • ECF: Epirubicin, Cisplatin, and continuous-infusion Fluorouracil.
        • ECX: Epirubicin, Cisplatin, and Capecitabine (an oral prodrug of fluorouracil).
      • After 2017 Amendment: Patients received four cycles before surgery and four cycles after surgery of:
        • FLOT: Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel.

    2. Perioperative Chemotherapy Plus Preoperative Chemoradiotherapy Group (Experimental Group):

    • Modifications to Chemotherapy:
      • Received one less cycle of preoperative chemotherapy compared to the control group to accommodate the addition of radiotherapy.
      • Postoperative chemotherapy was the same as in the control group.
    • Preoperative Chemoradiotherapy:
      • Chemoradiotherapy Definition: Concurrent administration of chemotherapy and radiotherapy before surgery.
      • Radiotherapy Regimen:
        • Total dose of 45 Gy, delivered in 25 fractions over 5 weeks (1.8 Gy per fraction, 5 days per week).
        • Target Area: Entire stomach, any perigastric tumor extension, and regional lymph nodes.
      • Concurrent Chemotherapy During Radiotherapy:
        • Continuous infusion of Fluorouracil (200 mg/m² per day) 7 days a week during radiotherapy.
        • Alternatively, Capecitabine (825 mg/m² twice daily on days 1–5 of each radiotherapy week) could be used.
  • Surgical Procedure:
    • Surgery was performed 4–6 weeks after completion of preoperative therapy.
    • Recommended surgery included total gastrectomy, subtotal distal gastrectomy, or esophagogastrectomy with D2 lymphadenectomy (removal of additional lymph node stations beyond the immediate perigastric nodes).

Endpoints:

  • Primary Endpoint: Overall survival (time from randomization to death from any cause).
  • Secondary Endpoints: Progression-free survival, pathological complete response rate (no residual tumor in the resected specimen), treatment-related toxic effects, and quality of life.

Results:

  • Pathological Findings:
    • Pathological Complete Response Rate:
      • Higher in the experimental group (preoperative chemoradiotherapy) at 17% compared to 8% in the control group.
    • Tumor Downstaging:
      • More patients in the experimental group had their tumors downstaged to a lower T category and had fewer involved lymph nodes.
  • Survival Outcomes:
    • Overall Survival:
      • Median Overall Survival:
        • Experimental Group: 46 months.
        • Control Group: 49 months.
      • Hazard Ratio for Death: 1.05 (95% CI, 0.83–1.31), indicating no significant difference between the groups.
    • Progression-Free Survival:
      • Median progression-free survival was similar between the groups (31 months vs. 32 months).
  • Treatment Adherence:
    • Preoperative Therapy Completion:
      • High completion rates in both groups for preoperative chemotherapy.
      • Slightly lower in the experimental group due to the addition of radiotherapy.
    • Postoperative Chemotherapy Completion:
      • Lower completion rates overall, with fewer patients in the experimental group completing postoperative chemotherapy (48% vs. 59%).
  • Adverse Events:
    • Similar rates of grade 3 or higher toxic effects in both groups.
    • No significant differences in surgical complications or postoperative mortality.

Conclusion:

Adding preoperative chemoradiotherapy to standard perioperative chemotherapy did not improve overall survival or progression-free survival in patients with resectable gastric and gastroesophageal junction adenocarcinoma, despite achieving higher pathological complete response rates and increased tumor downstaging. These findings suggest that the routine addition of preoperative chemoradiotherapy to perioperative chemotherapy does not confer additional survival benefits and should not change the current standard of care.

Clinical Implications:

  • Standard Treatment Remains Perioperative Chemotherapy:
    • Perioperative chemotherapy alone continues to be the standard approach for resectable gastric cancer.
    • Regimens like FLOT are preferred due to their demonstrated efficacy.
  • Role of Radiotherapy:
    • Routine use of preoperative radiotherapy in addition to chemotherapy is not supported by this trial’s findings.
    • Radiotherapy may still have a role in specific clinical scenarios, but not as a standard addition to perioperative chemotherapy.
  • Future Directions:
    • Further research may focus on identifying subgroups of patients who might benefit from chemoradiotherapy.
    • Biomarker-driven approaches and personalized treatment strategies could optimize outcomes.

Reference: Leong, T., et al. (2024). Preoperative Chemoradiotherapy for Resectable Gastric Cancer. The New England Journal of Medicine.  DOI: http://doi.org/10.1056/NEJMoa2405195

 

RCT: More Extensive Lymph Node Removal Does Not Improve Outcomes in Right-Sided Colon Cancer Surgery

7 Sep, 2024 | 09:56h | UTC

Study Design and Population: This multicenter, open-label, randomized controlled trial (RELARC) evaluated the efficacy of complete mesocolic excision (CME) versus D2 lymphadenectomy for right-sided colon cancer. Conducted across 17 hospitals in China, the study enrolled 1,072 patients with stage T2-T4aNanyM0 or TanyN+M0 disease. Participants were randomized (1:1) to undergo either CME or D2 dissection, and the primary outcome was 3-year disease-free survival (DFS), with 3-year overall survival (OS) as the main secondary outcome.

Main Findings: Among 995 analyzed patients, no significant differences were observed between CME and D2 groups in 3-year DFS (86.1% vs. 81.9%, HR 0.74, P = 0.06) or 3-year OS (94.7% vs. 92.6%, HR 0.70, P = 0.17). While CME trended toward better DFS, the results were not statistically significant.

Implications for Practice: Given the lack of significant survival benefit, the trial supports D2 dissection as the standard surgical approach for right-sided colon cancer. CME may be reserved for cases with evident mesocolic lymph node involvement.

Reference: Lu, J. et al. (2024). Extent of lymphadenectomy for surgical management of right-sided colon cancer: the randomized phase III RELARC trial. Journal of Clinical Oncology. http://doi.org/10.1200/JCO.24.00393

 

Cohort Study: Short-Course Radiotherapy with CAPOX Shows Favorable Outcomes in High-Risk Locally Advanced Rectal Cancer

7 Sep, 2024 | 09:38h | UTC

Study Design and Population: This Swedish nationwide cohort study examined total neoadjuvant treatment (TNT) for 273 patients with high-risk locally advanced rectal cancer (LARC) using short-course radiotherapy (5×5 Gy) followed by four cycles of CAPOX chemotherapy. Patients were treated between July 2016 and June 2020 across 16 hospitals, with 189 additional patients treated off-study. The study aimed to evaluate the complete response (CR) rate, comparing outcomes with the RAPIDO trial.

Main Findings: The CR rate, including both pathological complete response (pCR) and clinical complete response (cCR), was 24% (LARCT-US group) and 23% (AdmL group), comparable to the RAPIDO trial’s results. Locoregional recurrences were low (6% and 5%, respectively) after 3 years. Neurotoxicity was lower than in RAPIDO, and overall, the treatment was well tolerated. Notably, two fewer chemotherapy cycles did not compromise the CR rate.

Implications for Practice: While the study demonstrates promising outcomes using short-course radiotherapy and four CAPOX cycles for locally advanced rectal cancer (LARC), these findings are based on an observational study, which inherently limits the ability to draw definitive causal conclusions. Despite this, the real-world data suggests that a shorter chemotherapy regimen may be both feasible and effective. Further randomized trials are needed to confirm these results and assess long-term outcomes. Clinicians should cautiously apply this regimen, considering both the evidence and individual patient factors.

Reference: Glimelius, B. et al. (2024). Total Neoadjuvant Treatment Using Short-Course Radiotherapy and Four CAPOX Cycles in Locally Advanced Rectal Cancer with High-Risk Criteria for Recurrence: A Swedish Nationwide Cohort Study (LARCT-US). eClinicalMedicine. http://doi.org/10.1016/j.eclinm.2024.102771

 

Clinical Trial Follow-Up: Continued Imatinib Significantly Extends Survival and Delays Resistance in Advanced GIST – The Lancet Oncology

25 Aug, 2024 | 11:55h | UTC

Study Design and Population: This exploratory long-term follow-up of the BFR14 open-label, multicenter, randomized phase 3 trial involved patients with advanced gastrointestinal stromal tumors (GIST) across 17 cancer centers in France. The trial included patients aged 18 years or older with stable disease after 1, 3, or 5 years of treatment with imatinib. Participants were randomized to either continue or discontinue imatinib until disease progression, with primary endpoint analysis focused on progression-free survival (PFS).

Main Findings: Imatinib continuation significantly extended PFS compared to discontinuation, with median PFS ranging from 27.8 to over 67.0 months in the continuation group versus 6.1 to 12.0 months in the interruption group, depending on the duration of prior treatment (p-values <0.002). Additionally, continuing imatinib delayed resistance and improved overall survival, particularly notable after 3 years of treatment, with a median overall survival of 134.0 months compared to 104.0 months in the discontinuation group (HR 0.40, p=0.0096).

Implications for Practice: These findings strongly discourage the interruption of imatinib in GIST patients who are stable or responding to treatment, as it leads to worse long-term outcomes, including quicker disease progression and increased resistance to the therapy.

Reference: Blay JY et al. (2024). Discontinuation versus continuation of imatinib in patients with advanced gastrointestinal stromal tumours (BFR14): exploratory long-term follow-up of an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. http://doi.org/10.1016/S1470-2045(24)00318-8

 

RCT: Cold Snare EMR Reduces Major Adverse Events but Increases Residual Adenoma in Large Nonpedunculated Colorectal Polyps – Gastroenterology

25 Aug, 2024 | 11:45h | UTC

Study Design and Population: This multicentric randomized controlled trial (RCT) involved 19 centers in Germany and included 363 patients with 396 large nonpedunculated colorectal polyps (≥20 mm). Participants were randomly assigned to undergo either cold snare endoscopic mucosal resection (EMR) or the traditional hot snare EMR. The study aimed to compare the safety and effectiveness of cold versus hot snare EMR.

Main Findings: Cold snare EMR significantly reduced the incidence of major adverse events (AEs), with a major AE rate of 1.0% compared to 7.9% in the hot snare group. This included significant reductions in perforation and postendoscopic bleeding rates. However, cold snare EMR was associated with a higher rate of residual adenoma at follow-up, with 23.7% of cases compared to 13.8% in the hot snare group. The increased rate of residual adenoma was particularly noted in larger lesions (≥4 cm) and those with high-grade dysplasia.

Implications for Practice: Cold snare EMR offers a safer alternative to hot snare EMR for resecting large nonpedunculated colorectal polyps, particularly in terms of reducing major AEs. However, the higher rate of residual adenoma indicates that cold snare EMR should be used selectively, especially for smaller polyps or less likely to have advanced histology. Further research is needed to refine lesion selection criteria and to explore technical modifications that could improve the efficacy of cold snare EMR.

Reference: Steinbrück, I., et al. (2024). Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial. Gastroenterology, 167(4), 764–777. http://doi.org/10.1053/j.gastro.2024.05.013

 

Meta-Analysis: ERAS Protocols Improve Recovery and Reduce Complications After Emergency Laparotomy – Am J Surg

18 Aug, 2024 | 19:32h | UTC

Study Design and Population: This systematic review and meta-analysis assessed the effects of Enhanced Recovery After Surgery (ERAS) protocols compared to standard care (SC) in patients undergoing emergency laparotomy. The analysis included six randomized clinical trials (RCTs) with a total of 509 patients.

Main Findings: The ERAS group showed a reduction in length of hospital stay (mean difference: -2.92 days) and quicker recovery milestones, such as time to ambulation (mean difference: -1.67 days) and first bowel opening (mean difference: -1.26 days). The ERAS protocols were also associated with lower rates of pulmonary complications (odds ratio [OR]: 0.43) and surgical site infections (OR: 0.33). Mortality rates were similar between the ERAS and SC groups.

Implications for Practice: These findings suggest that ERAS protocols may enhance recovery and reduce complications in patients undergoing emergency laparotomy. Implementation of these protocols could be beneficial in emergency surgical settings, where feasible.

Reference: Amir AH, Davey MG, Donlon NE. (2024). Evaluating the Impact of Enhanced Recovery After Surgery Protocols following Emergency Laparotomy – A Systematic Review and Meta-Analysis of Randomised Clinical Trials. The American Journal of Surgery. DOI: https://doi.org/10.1016/j.amjsurg.2024.115857.

 

Systematic Review: Nasogastric Feeding Increases Diarrhea and Pain Compared to Nasojejunal Feeding in Acute Pancreatitis – BMC Gastroenterol

18 Aug, 2024 | 19:23h | UTC

Study Design and Population: This systematic review and meta-analysis compared the safety and efficacy of nasogastric (NG) versus nasojejunal (NJ) feeding initiated within 48 hours of hospital admission in patients with moderate to severe acute pancreatitis. The analysis included four randomized controlled trials (RCTs) involving a total of 217 patients.

Main Findings: The review found no significant difference in mortality between NG and NJ feeding groups. However, NG feeding was associated with a higher incidence of diarrhea (RR 2.75, P = 0.02) and pain (RR 2.91, P = 0.002). The risk of infection was also higher in the NG group (6.67% vs. 3.33%, P = 0.027). No significant differences were observed in the need for surgical intervention, the requirement for parenteral nutrition, or the success rates of feeding procedures.

Implications for Practice: The findings suggest that while NG feeding does not increase mortality in acute pancreatitis, it is associated with higher rates of certain complications, particularly diarrhea and pain. Clinicians should consider these risks when choosing a feeding strategy for patients with acute pancreatitis, especially within the critical early 48-hour period post-admission.

Reference: Wang M, Shi H, Chen Q, Su B, Dong X, Shi H, Xu S. (2024). Comparative safety assessment of nasogastric versus nasojejunal feeding initiated within 48 hours post-admission versus unrestricted timing in moderate or severe acute pancreatitis: a systematic review and meta-analysis. BMC Gastroenterology, 24(207), 1-11. DOI: 10.1186/s12876-024-03290-z.

 

Randomized Noninferiority Trial: Oral Vonoprazan Noninferior to IV Proton Pump Inhibitors in Preventing Rebleeding of High-Risk Peptic Ulcers – Gastroenterology

18 Aug, 2024 | 18:32h | UTC

Study Design and Population: This multicenter, randomized, open-label, noninferiority trial was conducted in Thailand across six centers, including both university and community hospitals. A total of 194 patients with high-risk peptic ulcer (PU) bleeding who had achieved successful endoscopic hemostasis were randomized to receive either vonoprazan or intravenous proton pump inhibitors (PPI). The study aimed to compare the efficacy of vonoprazan, a potassium-competitive acid blocker, with that of high-dose PPIs in preventing rebleeding.

Main Findings: The trial found that the 30-day rebleeding rate in the vonoprazan group was 7.1%, compared to 10.4% in the PPI group. This demonstrated noninferiority of vonoprazan within a 10% margin (risk difference: -3.3%, 95% CI: -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates were also noninferior. Secondary outcomes, including mortality rates, the need for rescue therapy, blood transfusion requirements, and length of hospital stay, were comparable between the two groups. Adverse events were similar in both groups.

Implications for Practice: Vonoprazan presents a viable alternative to intravenous PPIs for preventing rebleeding in patients with high-risk PU after endoscopic hemostasis. The availability of vonoprazan in oral form could potentially reduce hospital stays. However, further studies in multiethnic populations are needed to confirm these findings and assess the cost-effectiveness of vonoprazan in this setting.

Reference: Geeratragool T, Kaosombatwattana U, Boonchote A, et al. (2024). Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology, -(-), 1-10. DOI: https://doi.org/10.1053/j.gastro.2024.03.036.

 

Network Meta-Analysis: Preoperative Chemoradiotherapy and Chemotherapy Equally Improve Survival in Esophagogastric Adenocarcinoma – JAMA Netw Open

17 Aug, 2024 | 19:21h | UTC

Study Design and Population: This network meta-analysis included 17 randomized clinical trials (RCTs) with a total of 2,549 patients, predominantly male (86.5%), with a mean age of 61 years. The study compared the effects of preoperative chemoradiotherapy (CRT) versus preoperative and/or perioperative chemotherapy, and surgery alone on overall survival and disease-free survival in patients with adenocarcinoma of the esophagus and esophagogastric junction (AEG).

Main Findings: Both preoperative CRT plus surgery (HR, 0.75) and preoperative/perioperative chemotherapy plus surgery (HR, 0.78) significantly improved overall survival compared to surgery alone. Disease-free survival was similarly prolonged with both treatments. No significant difference was observed between CRT and chemotherapy in overall survival, though CRT was associated with higher postoperative morbidity.

Implications for Practice: The findings suggest that both preoperative CRT and preoperative/perioperative chemotherapy are effective in extending survival in AEG patients, with no clear superiority of one approach over the other. Clinicians can consider either modality based on patient-specific factors, although the increased morbidity associated with CRT warrants careful consideration.

Reference: Ronellenfitsch U, Friedrichs J, Barbier E, et al. (2024). Preoperative Chemoradiotherapy vs Chemotherapy for Adenocarcinoma of the Esophagogastric Junction: A Network Meta-Analysis. JAMA Network Open, 7(8), e2425581. DOI: 10.1001/jamanetworkopen.2024.25581.

 

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