Status:
COMPLETED
Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Penn State University
University of Milan
Conditions:
Colorectal Cancer
Polyp of Colon
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Endoscopic Mucosal Resection (EMR) is the current standard for effective endoscopic resection of such colon adenomas. If resection is possible in one piece (so-called "en bloc" resection) then recurre...
Detailed Description
This is a prospective, multi-center study enrolling patients with non-pedunculated colorectal polyps ≥ 20mm for endoscopic mucosal resection (EMR). All primary EMR procedures will combine EMR with h-A...
Eligibility Criteria
Inclusion
- All Ethnicity and race
- Patient referred for endoscopic resection of all colorectal polyps non-pedunculated equal or greater 20 mm
- Written informed consent
Exclusion
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Previous partial EMR
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- 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
- Poor bowel preparation (Boston bowel prep score ≤2)
- Target sign or perforation during initial EMR
- Need for ESD for complete resection prior to APC
- Pregnancy and breast-feeding.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT04015765
Start Date
August 26 2019
End Date
January 8 2025
Last Update
March 18 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec, Canada