Colon Adenoma, Colon Cancer, Colon Polyp, Serrated Polyp
Conditions
Keywords
Polyp Resection, Cold Snare, Cold Endoscopic Mucosal Resection (Cold EMR), Cold Snare Piecemeal Resection (CSPR), Colonoscopy
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.
Interventions
PROCEDURECold Snare Piecemeal Resection (CSPR)
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
PROCEDURECold Snare Endoscopic Mucosal Resection (Cold EMR)
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Sponsors
Rush University Medical Center
University of Colorado, Denver
John D. Dingell VA Medical Center
White River Junction Veterans Affairs Medical Center
University of Kansas Medical Center
Vancouver Coastal Health
Université de Montréal
University of Alabama at Birmingham
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy 3. 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) 4. Ability to provide informed consent
Exclusion criteria
1. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp) 2. 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) 3. Patients with Ulcerative Colitis or Crohn's disease 4. Polyps with features suggestive of submucosal invasion 5. Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum) 6. 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 7. Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Resection (Central Post-Resection Biopsies) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Time | 1 day | The total time it takes to complete the colonoscopy procedure |
| Polyp Resection Time | 1 day | The time it takes to remove the polyp completely |
| Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm | At first surveillance colonoscopy, typically 6 months to 12 months | The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy |
| Adverse Events | 30 Days | The number of complications for each randomization arm during and after the procedure |
| Resection Preparation Time | 1 day | The time it takes to prepare for polyp removal |
Countries
United States
Outcome results
None listed