Recruiting

Endoscopic Mucosal Resection

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06807073

Conditions

Colorectal Cancer

Polyp of Colon

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prophylactic defect closure

No prophylactic defect closure

Study Details

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

Study ID

NCT06807073

Start date

Feb 27, 2025

Status verified date

Apr, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

686 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

active comparator: Endoscopic Mucosal Resection (EMR)

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

Interventions

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.

No prophylactic defect closure

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

Primary outcome measure

  • Delayed bleeding [ Time Frame: 14 days ]
  • Delayed perforation [ Time Frame: 14 days ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada

Contacts

Samira Hanin

514-890-8000samira.hanin.chum@ssss.gouv.qc.ca

Principal Investigator:

Daniel von Renteln, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Sep 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-09-08.