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Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps

NCT07242820 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2025-11-21

No results posted yet for this study

Summary

The goal of this clinical trial is to clarify the role of adjuvant thermal ablation for non-thermal endoscopic mucosal resection (EMR) of large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions \[LSLs\]).

The hypothesis is that adding adjuvant thermal ablation to non-thermal EMR (vs no ablation) will result in lower lesion recurrence rates at 6-month follow-up, and non-inferior adverse events (AE) rates 14 days post EMR.

For participants with planned EMR, endoscopists will perform non-thermal EMRs as per standard of care and:

* adjuvant thermal ablation will either not be performed (control group), or will be applied to the base and outside margins of the resection site (experimental group);
* then, all patients will be contacted 14-44 days after EMR, to verbally ascertain the occurrence of AEs;
* then, all patients will undergo a first follow-up colonoscopy at 6 months after initial conoloscopy to assess lesion recurrence;
* finally, all patients will undergo a second and final colonoscopy 18 months after EMR.

Conditions

Interventions

PROCEDURE

Adjuvant thermal ablation

When the endoscopist determines that the resection is complete, submucosal injection (0.9% NaCl with methylene blue solution) using the h-APC probe (ERBEJET 2 attached to Vio3 electrosurgical unit, pressure: 40 bar) will be performed to further expose the resection margin. Adjuvant thermal ablation will be applied to the outside margins of the resection site using the h-APC probe. Adjuvant thermal ablation will then also be applied to the base of the resection site using the h-APC probe. The precise electrocautery mode (PRECISE-APC setting 9) will be used to apply thermal ablation, as previously described for h-APC.

PROCEDURE

No adjuvant thermal ablation

After performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2031-05-31
Completion
2032-05-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT07242820 on ClinicalTrials.gov