Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps

NCT06807073 | Recruiting DMC

• 1 other identifier: 2025-12350
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer; Polyp of Colon

Outcome Measures

Primary Outcomes (2)

• Delayed bleeding

  Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.

  14 days

• Delayed perforation

  Defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract

  14 days

Secondary Outcomes (4)

• Any delayed bleeding

  14 days

• Clinically significant delayed bleeding in the proximal colon

  14 days

• Clinically significant delayed bleeding in the distal colon

  14 days

• Lesion recurrence

  6 months

Other Outcomes (8)

• Defect closure time

  14 days

• Technical success for complete defect closure

  6 months

• Procedure costs

  18 months

Study Arms (2)

Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)

EXPERIMENTAL

Prophylactic defect closure will be performed using at least one new generation closure device.

Procedure: Prophylactic defect closure

Endoscopic Mucosal Resection (EMR)

ACTIVE COMPARATOR

After performing EMR with thermal ablation, prophylactic defect closure will not be performed.

Procedure: No prophylactic defect closure

Interventions

Prophylactic defect closure PROCEDURE

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.

Endoscopic Mucosal Resection (EMR) + prophylactic defect closure (defect closure)

No prophylactic defect closure PROCEDURE

After performing EMR with thermal ablation, prophylactic defect closure will not be performed.

Endoscopic Mucosal Resection (EMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult ≥18 years old
• patients undergoing EMR for a large (≥20mm) colorectal LSL
• patients providing written and informed consent for study participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist, MD

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca . To gain access, data requestors will need to sign a data access agreement

Locations

CA (1)