GI Surgery – Colorectal
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):
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]
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:
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
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
Large bowel obstruction | ED presentation, evaluation, and management
19 Jul, 2023 | 14:17h | UTCLarge bowel obstruction: ED presentation, evaluation, and management – emDocs
Consensus Paper | Colorectal neuroendocrine tumors
30 Jun, 2023 | 14:45h | UTC
Guidance on fecal immunochemical testing to help diagnose colorectal cancer among symptomatic patients in primary care
29 Jun, 2023 | 13:59h | UTC
SR | Supportive care interventions for managing gastrointestinal symptoms following treatment for colorectal cancer
22 Jun, 2023 | 14:49h | UTC
RCT | Hemostatic powder provides better control of gastrointestinal tumor bleeding than standard endoscopic treatment
20 Jun, 2023 | 12:39h | UTCHemostatic powder vs. standard endoscopic treatment for gastrointestinal tumor bleeding: A multicenter randomized trial – Gastroenterology (link to abstract – $ for full-text)
Position Statement | Curriculum for training in endoscopic mucosal resection in the colon
19 Jun, 2023 | 13:42h | UTC
M-A | Preoperative IV plus oral antibiotics reduce surgical site infections in elective colorectal surgery
14 Jun, 2023 | 14:31h | UTCRelated:
Commentary on Twitter
Recent network? #metaanalysis indicates that bowel prep w iv + oral antibiotics w/wo mech bowel prep results in ⤵️SSI? and anast insuff☔️ compared to other combinations in colorect?! https://t.co/pALtvscZCh#colorectalsurgery #StepUp4CRC #SoMe4Surgery @Mcfark @LauraLorenzonMD pic.twitter.com/KQSBk0NwEB
— BJS Open (@BjsOpen) June 5, 2023
RCT | Preoperative FOLFOX noninferior to chemoradiotherapy in locally advanced rectal cancer
7 Jun, 2023 | 14:06h | UTCPreoperative Treatment of Locally Advanced Rectal Cancer – New England Journal of Medicine (link to abstract – $ for full-text)
Related Publication: Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048) – Journal of Clinical Oncology
Commentary: Radiation May Be Safely Omitted in Select Patients With Locally Advanced Rectal Cancer – The ASCO Post
Commentary on Twitter
Original Article: Preoperative Treatment of Locally Advanced Rectal Cancer (PROSPECT) https://t.co/6ubagrEzyw#ASCO23 pic.twitter.com/g2XFBkEk4T
— NEJM (@NEJM) June 5, 2023
Cohort Study | Overweight or obesity in early and middle adulthood linked to higher gastrointestinal cancer risk
5 Jun, 2023 | 13:34h | UTCEditorial: Obesity and Gastrointestinal Cancer: A Life Course Perspective – JAMA Network Open
Commentary: Association Between Overweight/Obesity and Risk of Gastrointestinal Cancer – The ASCO Post
WSES consensus guidelines on sigmoid volvulus management
5 Jun, 2023 | 13:19h | UTCWSES consensus guidelines on sigmoid volvulus management – World Journal of Emergency Surgery
SR | Systematic review finds 16.4-36.18 severe bleedings, 7.62-8.5 perforations per 10,000 colonoscopies
1 Jun, 2023 | 12:15h | UTC
M-A | Prehabilitation may enhance functional capacity in pre- and postoperative colorectal cancer patients
30 May, 2023 | 11:50h | UTCSummary: Preparing a patient with bowel cancer for surgery with multiple interventions – Cochrane Library
AGA/ACG Guideline | Pharmacological management of chronic idiopathic constipation
22 May, 2023 | 13:53h | UTC
Review | Hereditary colorectal, gastric, and pancreatic cancer
18 May, 2023 | 13:43h | UTCHereditary colorectal, gastric, and pancreatic cancer: comprehensive review – BJS Open
Commentary on Twitter
Have a?at our latest comprehensive review covering all u need to know?about hereditary ?colorectal, gastric & pancreatic?! https://t.co/y1LL0DNRiy@Adductor @DrRABurkhart #SoMe4Surgery #StepUp4CRC #SurgEd #MedTwitter @BJSAcademy @BJSurgery @juliomayol @young_bjs Great read! pic.twitter.com/JmmOmMBydO
— BJS Open (@BjsOpen) May 11, 2023
Fluorescence-guided surgery: comprehensive review
18 May, 2023 | 13:34h | UTCFluorescence-guided surgery: comprehensive review – BJS Open
Commentary on Twitter
Find all you ever wanted to know about the current state of fluorescence-guided surgery ???in our latest comprehensive review by @BJSurgery editor @paulo_sutt et al. Absolutely worth reading!https://t.co/Tgrj4UvOzV@BJSAcademy @juliomayol @young_bjs #SoMe4Surgery #MedTwitter pic.twitter.com/ReArdO1LOs
— BJS Open (@BjsOpen) May 17, 2023
2023 Rectal cancer lexicon update | Revised consensus on terminology and staging
15 May, 2023 | 12:50h | UTC
SR | Same-day discharge vs. standard enhanced recovery after surgery (ERAS) protocols for major colorectal surgery
11 May, 2023 | 11:43h | UTC
Guideline | Use of non-invasive biomarkers for diagnosis of colorectal neoplasia
10 May, 2023 | 15:46h | UTC