Heiko Pohl1, Ian S Grimm2, Matthew T Moyer3, Muhammad K Hasan4, Douglas Pleskow5, B Joseph Elmunzer6, Mouen A Khashab7, Omid Sanaei7, Firas H Al-Kawas8, Stuart R Gordon9, Abraham Mathew2, John M Levenick2, Harry R Aslanian10, Fadi Antaki11, Daniel von Renteln12, Seth D Crockett2, Amit Rastogi13, Jeffrey A Gill14, Ryan J Law15, Pooja A Elias6, Maria Pellise16, Michael B Wallace17, Todd A Mackenzie18, Douglas K Rex19. 1. Dartmouth Geisel School of Medicine, Hanover, New Hampshire; Section of Gastroenterology and Hepatology, VA White River Junction, White River Junction, Vermont. Electronic address: Heiko.pohl@dartmouth.edu. 2. Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina. 3. Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. 4. Center for Interventional Endoscopy, Florida Hospital, Orlando, Florida. 5. Division of Gastroenterology Beth Israel Deaconess Medical Center, Boston, Massachusetts. 6. Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, South Carolina. 7. Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland. 8. Division of Gastroenterology and Hepatology, Johns Hopkins University, Sibley Memorial Hospital, Washington, DC. 9. Dartmouth Geisel School of Medicine, Hanover, New Hampshire; Department of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire. 10. Section of Digestive Diseases, Yale-New Haven Hospital, New Haven, Connecticut. 11. Division of Gastroenterology, John D. Dingell Veterans Affairs Medical Center and Wayne State University, Detroit, Michigan. 12. Division of Gastroenterology, University of Montreal Medical Center (CHUM) and Research Center (CRCHUM), Montreal, QC, Canada. 13. Division of Gastroenterology, Hepatology and Motility, University of Kansas Medical Center, Kansas City, Kansas. 14. Division of Gastroenterology James A. Haley VA, University of South Florida, Tampa, Florida. 15. Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan. 16. Gastroenterology Department, Hospital Clínic de Barcelona, Barcelona, Spain. 17. Division of Gastroenterology and Hepatology, Mayo Clinic Jacksonville, Jacksonville, Florida. 18. The Dartmouth Institute, Department for Biomedical Data Science, Lebanon, New Hampshire. 19. Indiana University School of Medicine, Indianapolis, Indiana.
Abstract
BACKGROUND & AIMS: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS:A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). CONCLUSIONS: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.
RCT Entities:
BACKGROUND & AIMS:Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). CONCLUSIONS: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.
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