What this study is
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.
What's being tested
- Cold Snare Piecemeal Resection (CSPR)
Intervention · PROCEDURE
Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)
- Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Intervention · PROCEDURE
Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)
Study details
- Official title
- Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)
- Sponsor
- Indiana University
- Conditions
- Colon Polyp · Colon Adenoma · Serrated Polyp
- Enrolling
- 570 people
- Starts
- 2024-09-06
- Est. completion
- 2028-07
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
University of Colorado
Aurora, Colorado, United States
Rush University
Chicago, Illinois, United States
IU Health University Hospital
Indianapolis, Indiana, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
John D. Dingell VA Medical Center
Detroit, Michigan, United States
White River Junction VA Medical Center
White River Junction, Vermont, United States
2 sites outside the US
University of British Columbia
Vancouver, British Columbia, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Study team
Sponsor
Indiana University
Study ID 20831
Principal investigator
John J Guardiola, MD
Indiana University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.