Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06462521

Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Colon Cancer Colon Adenoma Colon Polyp Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Serrated Polyp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold Snare Piecemeal Resection (CSPR)

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)

Procedure

Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)

Primary outcomes

  1. 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.

  2. 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

  1. Polyp Resection Time

    Time frame: 1 day

    The time it takes to remove the polyp completely

  2. Resection Preparation Time

    Time frame: 1 day

    The time it takes to prepare for polyp removal

  3. Total Procedure Time

    Time frame: 1 day

    The total time it takes to complete the colonoscopy procedure

  4. Adverse Events

    Time frame: 30 Days

    The number of complications for each randomization arm during and after the procedure

  5. Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm

    Time frame: At first surveillance colonoscopy, typically 6 months to 12 months

    The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • John D. Dingell VA Medical Center
  • Rush University Medical Center
  • University of Alabama at Birmingham
  • University of Colorado, Denver
  • University of Kansas Medical Center
  • Université de Montréal
  • Vancouver Coastal Health
  • White River Junction Veterans Affairs Medical Center

Registry information

Official study 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)

Acronym: CARDINAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.