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

NCT07242820 | Not Yet Recruiting DMC

• 1 other identifier: 2026-13165
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Polyp of Colon

Outcome Measures

Primary Outcomes (2)

• Lesion recurrence rate

  Defined as the number of cases with pathology-confirmed hyperplastic, serrated, or adenomatous histology at the tattooed resection site compatible with the study polyp histology divided by the total number of cases.

  6 months

• Clinically significant adverse event (AE) rate

  Defined as the number of cases with delayed bleeding (blood per rectum resulting in emergency room visit, unplanned hospitalization, endoscopic, radiologic, or surgical intervention) and/or delayed perforation (endoscopic or radiologic evidence of significant air or any luminal contents outside the gastrointestinal tract) divided by the total number of cases.

  14 days

Secondary Outcomes (2)

• Any delayed bleeding rate

  14 days

• Lesion recurrence rate at 18-month follow-up

  18 months

Other Outcomes (8)

• High-grade dysplasia rate at the 18-month follow-up

  18 months

• Rate of CRC during the 18-month follow-up period

  From enrollment to the final follow-up colonoscopy at 18 months

• Colonoscopies to lesion clearance

  18 months

Study Arms (2)

Endoscopic mucosal resection (EMR) + adjuvant thermal ablation

EXPERIMENTAL

Adjuvant thermal ablation will be applied to the base and outside margins of the resection site after non-thermal EMR.

Procedure: Adjuvant thermal ablation

Endoscopic mucosal resection (EMR)

ACTIVE COMPARATOR

After non-thermal EMR, no adjuvant thermal ablation will be performed.

Procedure: No adjuvant thermal ablation

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.

Endoscopic mucosal resection (EMR) + adjuvant thermal ablation

No adjuvant thermal ablation PROCEDURE

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

Endoscopic mucosal resection (EMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Undergoing EMR for large (≥20 mm) colorectal LSL
• Providing written and informed consent for study participation

You may not qualify if:

• Inflammatory bowel disease
• Non-elective colonoscopy
• Poor general health (American Society of Anesthesiologists classification \>III)
• Coagulopathy or thrombocytopenia (international normalized ration ≥1.5 or platelets \<50\*10\^9/L)
• Bulky lesions (granular mixed with ≥10mm module).

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to daniel.von.renteln.med@ssss.gouv.qc.ca. To gain access, data requestors will need to sign a data access agreement.

Locations

CA (1)