Comparing closure techniques after removing large colorectal polyps
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: a Randomized Controlled Trial
This study tests if closing the site after removing large flat colorectal polyps can help prevent complications and reduce the chance of the polyps coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 686 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06807073 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the rates of adverse events and lesion recurrence following endoscopic mucosal resection (EMR) of large flat colorectal polyps, specifically laterally spreading lesions. Participants will be randomly assigned to either a control group, where no defect closure is performed, or an experimental group, where complete defect closure is applied after EMR. The study will monitor patients for adverse events and recurrence through follow-up assessments at 6 and 18 months post-procedure. The trial is designed to determine if defect closure can reduce complications associated with EMR.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for EMR of large colorectal laterally spreading lesions.
Not a fit: Patients with inflammatory bowel disease, non-elective colonoscopy needs, or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing EMR for large colorectal polyps.
How similar studies have performed: While similar studies have explored EMR techniques, this specific approach to defect closure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult ≥18 years old * patients undergoing EMR for a large (≥20mm) colorectal LSL * patients providing written and informed consent for study participation. Exclusion Criteria: * 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.
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.