Gastroenterology (all articles)
FDA grants approval for Colosense, a noninvasive stool RNA-based test for colorectal cancer screening
11 May, 2024 | 17:48h | UTCGeneoscopy, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense™, a noninvasive stool RNA-based test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for CRC.
Test Performance and Specifications:
– Sensitivity and Specificity: In the CRC-PREVENT trial, ColoSense demonstrated a sensitivity of 93% for detecting colorectal cancer and 45% sensitivity for detecting advanced adenomas (AA).
– Technology: ColoSense employs a multi-target stool RNA (mt-sRNA) approach, detecting colorectal neoplasia-associated RNA markers and occult hemoglobin. This method is designed to overcome variability in test performance that can occur with age-related changes in other biomarkers.
– Breakthrough Device Designation: The test has been designated as a Breakthrough Device by the FDA, acknowledging its potential to offer more effective diagnosis compared to existing methods.
– Accessibility: ColoSense is intended to facilitate increased screening uptake by providing a noninvasive alternative to traditional colonoscopy, particularly among populations reticent about invasive procedures.
Clinical Application:
– Screening Recommendations: Approved for individuals at typical average risk for CRC, ColoSense aligns with updated screening guidelines that recommend starting CRC screening at age 45.
– Role in Screening Strategy: ColoSense is indicated for use as a screening tool but is not intended to replace diagnostic or surveillance colonoscopy in individuals at high risk for CRC.
Geneoscopy is working towards a commercial launch of ColoSense in collaboration with Labcorp (NYSE: LH), aiming to make the test available by late 2024 or early 2025. (link to news release)
Cohort Study: Extending colonoscopy intervals to 15 years seems feasible in after a negative initial test in individuals without family history of CRC – JAMA Oncol
6 May, 2024 | 06:25h | UTCThis cohort study analyzed Swedish register-based data, examining colorectal cancer (CRC) diagnoses and CRC-specific mortality. The study included 110,074 individuals with a negative first colonoscopy (exposed group) and 1,981,332 matched controls, from 1990 to 2018. Participants were aged 45 to 69 at initial screening and were followed for up to 29 years.
During the follow-up, 484 new CRC cases and 112 CRC-specific deaths occurred in the exposed group. The study found significantly lower risks of CRC and CRC-specific death in the exposed group compared to controls over 15 years. The data suggest extending the screening interval from 10 to 15 years could miss only 2 CRC cases and prevent 1 CRC-specific death per 1,000 individuals while potentially reducing unnecessary colonoscopies.
The findings suggest that for individuals with no family history of CRC and a negative initial screening, the standard 10-year colonoscopy interval could safely be extended to 15 years. This adjustment could decrease the number of invasive procedures without significantly impacting cancer incidence and mortality, optimizing resource allocation and reducing patient burden.
Reference (link to abstract – $ for full-text):
Systematic Review: Comparing antibiotic treatment vs. appendectomy for the initial treatment of uncomplicated appendicitis – Cochrane Library
4 May, 2024 | 13:09h | UTCStudy Design and Population:
This Cochrane review analyzed 13 randomized controlled trials involving 3,358 participants to compare the efficacy of antibiotic treatment versus appendectomy in managing uncomplicated acute appendicitis. The included studies predominantly involved adult participants and utilized broad-spectrum antibiotics, with interventions ranging from open to predominantly laparoscopic appendectomy. Data collection spanned from hospital admission to up to seven years, with studies conducted across various global regions, including Asia, Europe, and North America.
Main Findings:
The primary outcomes revealed that antibiotic treatment might slightly increase the risk of unsuccessful treatment with 76 additional unsuccessful cases per 1,000 individuals compared to surgery, though these results did not reach clinical significance. Antibiotics reduced wound infections but possibly increased the average hospital stay by half a day. About 30.7% of participants treated with antibiotics required an appendectomy within one year. Secondary outcomes showed very uncertain evidence on antibiotics’ effect on intra-abdominal abscess or reoperation rates, and a slight increase in negative appendectomy rates was observed.
Implications for Practice:
The findings suggest that while antibiotics could serve as an initial treatment to avoid surgery in two-thirds of cases annually, a significant portion may still require surgical intervention. This information is crucial for clinicians in making informed treatment decisions, particularly considering patient preferences and the risk of surgery. Further research is needed to explore long-term outcomes and identify patient subgroups that may benefit most from either treatment.
Reference (link to abstract – $ for full-text):
RCT: Olezarsen effectively reduces triglyceride levels and pancreatitis episodes in familial chylomicronemia Syndrome
28 Apr, 2024 | 16:47h | UTCThis phase 3, double-blind, placebo-controlled trial evaluated olezarsen in 66 patients with familial chylomicronemia syndrome. Participants received 80 mg or 50 mg of olezarsen or a placebo subcutaneously every 4 weeks for 49 weeks. The study found significant reductions in fasting triglyceride levels at the 6-month mark in the 80 mg olezarsen group compared to the placebo (-43.5 percentage points), with a similar trend observed in apolipoprotein C-III levels. Furthermore, the incidence of acute pancreatitis was significantly lower in both olezarsen groups compared to placebo by the 53-week endpoint. The findings suggest olezarsen as a potent therapy for reducing triglyceride levels and preventing pancreatitis in this population.
Reference (link to abstract – $ for full-text):
ACG Guideline: Management of Acute Pancreatitis
20 Mar, 2024 | 21:49h | UTCThis guideline, crafted by the American College of Gastroenterology, provides essential strategies for managing acute pancreatitis, offering a concise overview of diagnosis, treatment, and prevention recommendations for healthcare professionals. Here is a summary of the key information contained in the document:
- Introduction and Epidemiology: Acute pancreatitis (AP) is one of the most common gastrointestinal diseases leading to hospitalization in the United States, with about 300,000 admissions annually and a cost of over 2.5 billion dollars. The incidence of AP has been increasing annually, although the mortality rate has remained stable due to advancements in management.
- Etiology and Diagnosis: AP is typically caused by gallstones and alcohol consumption. Diagnosis is made based on the presence of two of the following three criteria: characteristic abdominal pain, serum amylase and/or lipase levels more than three times the upper limit of normal, and/or characteristic findings on abdominal imaging.
- Initial Management and Hydration: Initial management emphasizes the importance of moderate to aggressive intravenous hydration, preferably with lactated Ringer’s solution over normal saline, due to its potential benefit in reducing systemic inflammation and preventing complications.
- Nutrition: Patients with mild AP are encouraged to start early oral feeding within 24 to 48 hours as tolerated, preferring a low-fat solid diet over a progressive approach from liquids to solids.
- Management of Complications: The document addresses the management of complications such as pancreatic necrosis, suggesting the use of antibiotics only in cases of infected necrosis and highlighting a preference for minimally invasive methods of debridement and necrosectomy.
- Prevention of Recurrence and Role of ERCP: To prevent recurrences in biliary pancreatitis, cholecystectomy is recommended. In selected cases of acute biliary pancreatitis without cholangitis, medical therapy is preferred over early ERCP.
- Use of Antibiotics: The guidelines discourage the prophylactic use of antibiotics in cases of severe AP without evidence of infection, due to the lack of demonstrated benefit and potential risks.
Tenner, S. et al (2024). American College of Gastroenterology Guidelines: Management of Acute Pancreatitis. The American Journal of Gastroenterology, 119(3), 419-437. https://doi.org/10.14309/ajg.0000000000002645
Clinical validation of a cell-free DNA test for colorectal cancer screening: sensitivity and specificity analysis
20 Mar, 2024 | 19:16h | UTCStudy Design and Population: This study conducted a clinical validation of a cell-free DNA (cfDNA) blood-based test to screen for colorectal cancer in a cohort of 10,258 individuals, 7,861 of whom met the eligibility criteria and were evaluable. The research aimed to assess the test’s performance by comparing its sensitivity for detecting colorectal cancer and its specificity for identifying advanced neoplasia (including colorectal cancer or advanced precancerous lesions) against the outcomes of screening colonoscopy, a standard procedure.
Main Findings: The cfDNA test demonstrated a sensitivity of 83.1% for detecting colorectal cancer, with stage-specific sensitivities of 87.5% for stages I-III cancers. However, its sensitivity for identifying advanced precancerous lesions was notably lower at 13.2%. On the specificity front, the test showed an 89.6% ability to correctly identify individuals without any advanced colorectal neoplasia and had an overall specificity of 89.9% for those with a negative colonoscopy result, indicating no presence of colorectal cancer, advanced precancerous lesions, or non-advanced precancerous lesions.
Implications for Practice: The cfDNA blood-based test presents a promising tool for colorectal cancer screening, boasting substantial sensitivity for colorectal cancer detection and high specificity for advanced neoplasia. Its non-invasive nature could potentially enhance screening adherence, facilitating earlier cancer detection and possibly reducing colorectal cancer-related mortality. However, the test’s low sensitivity for advanced precancerous lesions suggests a need for further research and development to improve early detection capabilities.
Reference: Chung, D.C. et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. Journal Name, Volume(Issue), Pages. Access the study here: [Link]
RCT: Effectiveness of mechanical and oral antibiotic bowel preparation in reducing postoperative complications in elective rectal resection
20 Mar, 2024 | 18:18h | UTCStudy Design and Population
This double-blind, placebo-controlled randomized clinical trial was conducted at three university hospitals in Finland, involving 565 patients aged 18 years and older undergoing elective rectal resection with primary anastomosis for tumors 15 cm or less from the anal verge, as determined by magnetic resonance imaging. Participants were allocated in a 1:1 ratio to either the mechanical and oral antibiotic bowel preparation (MOABP) group, receiving neomycin and metronidazole orally, or to the mechanical bowel preparation (MBP) plus placebo group, with all interventions occurring the day before surgery alongside standard preoperative intravenous antibiotics.
Main Findings
The study found that patients in the MOABP group experienced significantly fewer postoperative complications, with a median Comprehensive Complication Index significantly lower than that of the MBP plus placebo group. Additionally, the MOABP group showed reduced rates of surgical site infections (SSIs) and anastomotic dehiscence compared to the control group, demonstrating a clear benefit in postoperative outcomes.
Implications for Practice
The results of this trial suggest that incorporating oral antibiotics with mechanical bowel preparation prior to elective rectal resection significantly reduces postoperative complications, including SSIs and anastomotic dehiscence. Therefore, MOABP should be adopted as the standard regimen for patients undergoing these procedures to improve postoperative outcomes and reduce the burden of complications. This evidence underscores the importance of updating surgical protocols to include this preparation strategy.
Reference
Laura Koskenvuo et al. (2024). Randomized Clinical Trial: Effectiveness of Mechanical and Oral Antibiotic Bowel Preparation in Reducing Postoperative Complications in Elective Rectal Resection. JAMA Surg, Published online March 20, 2024. DOI: 10.1001/jamasurg.2024.0184. Access the study here: [Link]
Phase 2 RCT: Low-dose aspirin significantly reduces hepatic fat in MASLD patients without cirrhosis
20 Mar, 2024 | 17:48h | UTCStudy Design and Population: This phase 2, randomized, double-blind, placebo-controlled clinical trial was carried out over six months at a single hospital in Boston, Massachusetts. The study included 80 participants aged 18 to 70 years diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD) but without cirrhosis. Participants were randomly assigned to receive either 81 mg of daily aspirin (n=40) or placebo (n=40).
Main Findings: The trial revealed that aspirin significantly reduced the mean absolute change in hepatic fat content by -10.2% compared with placebo, as measured by proton magnetic resonance spectroscopy (MRS), with a statistically significant difference (P=0.009). Furthermore, aspirin treatment notably decreased relative hepatic fat content, increased the proportion of patients achieving a 30% or greater reduction in hepatic fat, and reduced both absolute and relative hepatic fat content as assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Adverse events were mostly minor, with upper respiratory infections and arthralgias being the most common.
Implications for Practice: These findings suggest that low-dose aspirin may be an effective intervention for reducing liver fat in adults with MASLD without cirrhosis, potentially offering a simple, accessible treatment option. However, the results are preliminary and call for further confirmation in larger, more diverse populations. The study underscores the importance of considering low-dose aspirin as part of management strategies for MASLD, pending further research.
Reference
Simon TG et al. (2024). Randomized Clinical Trial: Low-Dose Aspirin Significantly Reduces Hepatic Fat in MASLD Patients Without Cirrhosis. JAMA, 331(11), 920-929. DOI: 10.1001/jama.2024.1215. Access the study here: [Link]
Prospective Study: Enhanced detection of colorectal cancer and precancerous lesions with next-generation stool DNA testing
20 Mar, 2024 | 17:41h | UTCStudy Design and Population:
This prospective study evaluated the efficacy of a next-generation multitarget stool DNA test for colorectal cancer screening in asymptomatic adults aged 40 and older. The study encompassed 20,176 participants undergoing screening colonoscopy to determine the test’s sensitivity and specificity in detecting colorectal cancer and advanced neoplasia, including advanced precancerous lesions.
Main Findings:
The next-generation stool DNA test demonstrated a sensitivity of 93.9% for detecting colorectal cancer and a specificity of 90.6% for advanced neoplasia, significantly outperforming the fecal immunochemical test (FIT) in sensitivity for both colorectal cancer and advanced precancerous lesions. However, the test showed slightly lower specificity for advanced neoplasia compared to FIT. No adverse events were reported, indicating the test’s safety for screening purposes.
Implications for Practice:
The findings suggest that the next-generation multitarget stool DNA test offers a superior option for colorectal cancer screening, with significantly higher sensitivity for detecting cancer and advanced precancerous lesions than the currently available FIT. This advance in non-invasive screening technology could lead to earlier detection and treatment of colorectal cancer, potentially improving patient outcomes. Further research may focus on optimizing the balance between sensitivity and specificity to enhance the clinical utility of stool DNA testing.
Reference:
Perspective | Clinicians debate the usefulness of NAFLD name change
11 Aug, 2023 | 15:39h | UTCClinicians debate the usefulness of NAFLD name change – MDedge
Original article: From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization
Cohort Study | Moderate to heavy drinking linked to increased risk of early-onset colorectal cancer
9 Aug, 2023 | 15:27h | UTCCommentary: Association of Alcohol Intake With Risk of Early-Onset Colorectal Cancer – The ASCO Post
Commentary on Twitter
🧐 Moderate/heavy alcohol intake linked to increased risk of early-onset #ColorectalCancer, particularly distal colon & rectal cancers ➡️ https://t.co/2akaNsHbLu #CRCSM pic.twitter.com/5DGrrmdX4i
— Journal of Clinical Oncology (@JCO_ASCO) July 18, 2023
M-A | Percutaneous catheter drainage superior to needle aspiration for liver abscess treatment success
9 Aug, 2023 | 15:12h | UTC
Proposed algorithm for appropriate fluid management in acute pancreatitis
8 Aug, 2023 | 13:33h | UTCFluid treatment in acute pancreatitis: a careful balancing act – British Journal of Surgery
Related:
Update on the management of acute pancreatitis – Current Opinion in Critical Care
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis – New England Journal of Medicine
Acute Pancreatitis: Diagnosis and Treatment – Drugs
Evidence-Based Disposition of Acute Pancreatitis – emDocs
Pancreatitis – National Institute for Health and Care Excellence
Research: Endoscopic or Surgical Step-up Approach for Infected Necrotising Pancreatitis
Evidence-Based Approach to the Surgical Management of Acute Pancreatitis – The Surgery Journal
Clinical Trial Update | Long-term Givosiran treatment shows sustained acute hepatic porphyria symptom improvement
8 Aug, 2023 | 13:05h | UTCOriginal Study: Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria – New England Journal of Medicine
Review | Diagnosis and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome
4 Aug, 2023 | 11:50h | UTC
ACP Guidance | Asymptomatic CRC screening advised from age 50 with fecal occult blood test every 2 years or colonoscopy every 10 years
3 Aug, 2023 | 13:48h | UTCNews Release: ACP issues updated guidance for colorectal cancer screening of asymptomatic adults – American College of Physicians
Commentary: Start screening for colorectal cancer at age 50 years, ACP suggests – ACP Internist
Summary for Patients: Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults – Annals of Internal Medicine
Review | Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options
1 Aug, 2023 | 14:19h | UTCRelated:
From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization
Nonalcoholic fatty liver disease from a primary care perspective – Diabetes, Obesity and Metabolism
Management of NAFLD in primary care settings – Liver International
Non-alcoholic fatty liver disease: A patient guideline – JHEP Reports
RCT | Bictegravir regimen noninferior to dolutegravir regimen in HIV-1, HBV co-infection treatment
31 Jul, 2023 | 14:00h | UTC
AGA clinical practice update on evaluation and management of belching, abdominal bloating, and distention
27 Jul, 2023 | 13:04h | UTC
Review | Pediatric-onset inflammatory bowel disease: recent developments
27 Jul, 2023 | 12:57h | UTCInflammatory bowel disease: recent developments – Archives of Disease in Childhood
Podcast | Celiac disease pearls
27 Jul, 2023 | 12:53h | UTC#89: Celiac Disease – The Great Mimicker – The Cribsiders
Cohort Study | Proton pump inhibitor use linked to increased fatigue in kidney transplant recipients
26 Jul, 2023 | 13:21h | UTC
Commentary on Twitter
Proton Pump Inhibitor Use, Fatigue, and Health-Related Quality of Life in Kidney Transplant Recipients: Results From the TransplantLines Biobank and Cohort Study https://t.co/DkDTvs9zjo #OpenAccess#VisualAbstract @umcg pic.twitter.com/XooY16qFVT
— AJKD (@AJKDonline) July 25, 2023
Systematic Review | Dual therapy of Rifaximin and lactulose potentially reduces risk in hepatic encephalopathy
24 Jul, 2023 | 12:57h | UTC
RCT | Combined pre-operative olanzapine regimen lowers postoperative nausea in high-risk cancer patients
24 Jul, 2023 | 12:49h | UTC
Systematic Review | Medical treatment of eosinophilic esophagitis
21 Jul, 2023 | 13:27h | UTCMedical treatment of eosinophilic esophagitis – Cochrane Library
Summary: Medical treatments for eosinophilic esophagitis – Cochrane Library
Related:
M-A | Efficacy of elimination diets in eosinophilic esophagitis
RCT | Dupilumab in adults and adolescents with eosinophilic esophagitis