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Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
752
Start Date
2025-12
Completion Date
2032-05
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
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.
No adjuvant thermal ablation
After performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.
Locations (1)
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada