Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps (NCT07242820) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps
Canada752 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients
* Undergoing EMR for large (≥20 mm) colorectal LSL
* 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 ration ≥1.5 or platelets \<50\*10\^9/L)
* Bulky lesions (granular mixed with ≥10mm module).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lesion recurrence rate
Timeframe: 6 months
2
Clinically significant adverse event (AE) rate
Timeframe: 14 days
Trial details
NCT IDNCT07242820
SponsorCentre hospitalier de l'Université de Montréal (CHUM)