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

NCT06807073 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2025-02-11

No results posted yet for this study

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

Interventions

PROCEDURE

Prophylactic defect closure

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.

PROCEDURE

No prophylactic defect closure

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06807073 on ClinicalTrials.gov