Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Indiana University
- Enrollment
- 570
- Locations
- 2
- Primary Endpoint
- Efficacy of Resection (Central Post-Resection Biopsies)
Study Overview
Brief Summary
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age
- •Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
- •Found to have:
- •a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
- •a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
- •Ability to provide informed consent
Exclusion Criteria
- •Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- •Polyps confirmed to be anything other than:
- •sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
- •conventional adenoma on histologic diagnosis (Adenoma Cohort)
- •Patients with Ulcerative Colitis or Crohn's disease
- •Polyps with features suggestive of submucosal invasion
- •Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
- •Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:
- •Familial Adenomatous Polyposis Syndrome
- •MUTYH associated Polyposis Syndrome
- •Juvenile Polyposis Syndrome
- •Cowden's Syndrome
- •Peutz-Jeghers Syndrome
- •Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
Outcomes
Primary Outcomes
Efficacy of Resection (Central Post-Resection Biopsies)
Time Frame: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Efficacy of Resection (Peripheral Post-Resection Biopsies)
Time Frame: 1 day
Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.
Secondary Outcomes
- Polyp Resection Time(1 day)
- Resection Preparation Time(1 day)
- Total Procedure Time(1 day)
- Adverse Events(30 Days)
- Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm(At first surveillance colonoscopy, typically 6 months to 12 months)
Investigators
John J. Guardiola
Assistant Professor of Clinical Medicine
Indiana University