Status:
ACTIVE_NOT_RECRUITING
Cold Snare Endoscopic Mucosal Resection Trial
Lead Sponsor:
White River Junction Veterans Affairs Medical Center
Collaborating Sponsors:
Dartmouth College
Steris
Conditions:
Colonic Polyp
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 hal...
Detailed Description
Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that sna...
Eligibility Criteria
Inclusion
- Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
- Patients with a ≥20mm non-pedunculated colorectal polyp
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
990 Patients enrolled
Trial Details
Trial ID
NCT03865537
Start Date
October 1 2019
End Date
January 1 2027
Last Update
June 21 2024
Active Locations (1)
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1
White River Junction VAMC
White River Junction, Vermont, United States, 05009