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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT07242820
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adjuvant thermal ablation — PROCEDURE
    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.
  • No adjuvant thermal ablation — PROCEDURE
    After performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.

Study Details

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.

Key Dates

First listed
Nov 21, 2025
Start date
Dec 31, 2026
Status verified
Nov 2025
Primary completion
May 31, 2031
Completion
May 31, 2032

Study Design

Enrollment
752 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Endoscopic mucosal resection (EMR) + adjuvant thermal ablation
    Adjuvant thermal ablation will be applied to the base and outside margins of the resection site after non-thermal EMR.
  • Active Comparator: Endoscopic mucosal resection (EMR)
    After non-thermal EMR, no adjuvant thermal ablation will be performed.

Primary Outcome Measure

Lesion recurrence rate [ Time Frame: 6 months ]

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