IRB Study Number 25-126
Status Recruiting
Locations Cleveland Clinic Weston Hospital , Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
This study is for adults who are having a colonoscopy and are found to have a large flat or slightly raised polyp (20 mm or larger) in the colon that needs to be removed with endoscopic mucosal resection (EMR).
The goal is to compare two standard techniques for removing these large polyps:
Cold EMR: removing the polyp with a snare without using electric current (no cautery).
Hybrid cold EMR: removing the polyp with cold EMR, then treating any remaining visible tissue with hot avulsion and lightly burning (cauterizing) fibrotic bands in the resection area to destroy possible invisible polyp cells.
Both techniques are already used in routine practice. The study wants to know whether the hybrid technique lowers the chance that the polyp comes back without increasing the risk of complications such as bleeding, perforation, or post-polypectomy syndrome.
If you take part, your colonoscopy and polyp removal will be done as part of your usual care. You will be randomly assigned (like flipping a coin) to one of the two EMR techniques. You will get a follow-up colonoscopy about 3–6 months later so the doctor can check the resection site and take biopsies to see if any polyp tissue has come back. You will also receive a phone call about 48 hours after the procedure to check for problems such as pain, bleeding, or ER visits.
Inclusion Criteria
Age 18 years or older
Undergoing colonoscopy in which the doctor finds a non-pedunculated (flat or slightly raised) colorectal polyp
Polyp size ≥ 20 mm
Polyp morphology: flat or superficially raised
Paris 0-Is, 0-IIa, 0-IIb, or a combination of these
Polyp judged by the endoscopist to be suitable for EMR using the study techniques
Exclusion Criteria
Polyp at the same site with previous failed resection or known recurrent polyp
Features suggesting deep submucosal invasion on endoscopic appearance
e.g., Kudo V or NICE 3 pattern
Histologically confirmed invasive adenocarcinoma at that lesion
Polyp has nodules that are too large (>1–1.5 cm) to be safely removed with a cold snare
Known inflammatory bowel disease (IBD)
