Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: a Randomized Controlled Trial
Centre hospitalier de l'Université de Montréal (CHUM)
686 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs. The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed. For participants with planned EMR, endoscopists will perform EMRs as per standard of care and: * prophylactic defect closure will either not be performed (control group), or will be performed (experimental group); * then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event; * finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
Eligibility
Inclusion Criteria3
- adult ≥18 years old
- patients undergoing EMR for a large (≥20mm) colorectal LSL
- patients providing written and informed consent for study participation.
Exclusion Criteria8
- inflammatory bowel disease;
- non-elective colonoscopy;
- poor general health (American Society of Anesthesiologists classification \>III);
- coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets \<50 x 109/L);
- pedunculated polyps (Paris class Ip, Isp);
- overt signs of deep submucosal invasive cancer (JNET 3);
- appendiceal orifice or terminal ileum invasion;
- pregnancy.
Interventions
Endoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas \>3 mm along the closure line are present.
After performing EMR with thermal ablation, prophylactic defect closure will not be performed.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06807073