Cold Snare Endoscopic Mucosal Resection Trial

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Colonic Polyp, Colonoscopy, Complication, Recurrence

In brief

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Key facts

Study ID: NCT03865537
Run by: White River Junction Veterans Affairs Medical Center
People needed: 990
Starts: 2019-10-01
Expected to finish: 2027-01-01
Last updated by the study team: 2024-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
Patients with a ≥20mm non-pedunculated colorectal polyp

You may not qualify if…

Pedunculated polyps (as defined by Paris Classification type Ip)
Suspected adenocarcinoma with deep submucosal invasion
Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
Patients with inflammatory bowel disease
Patients who are receiving an emergency colonoscopy
Poor general health (ASA class>3)
Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
Pregnancy

Where it is running

White River Junction VAMC — White River Junction, Vermont, United States

Full record on ClinicalTrials.gov

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