Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection (CARDINAL)

December 22, 2025 updated by: John J. Guardiola, Indiana University

Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection: A RandomizeD Trial IN Colorectal Adenomas 10-19mm and Serrated Lesions ≥ 10mm (CARDINAL Study)

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

570

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Snare Piecemeal Resection (CSPR)
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.
Procedure: Cold 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.)
Experimental: Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.
Procedure: Cold 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp Resection Time
Time Frame: 1 day
The time it takes to remove the polyp completely
1 day
Total Procedure Time
Time Frame: 1 day
The total time it takes to complete the colonoscopy procedure
1 day
Adverse Events
Time Frame: 30 Days
The number of complications for each randomization arm during and after the procedure
30 Days
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
At first surveillance colonoscopy, typically 6 months to 12 months
Resection Preparation Time
Time Frame: 1 day
The time it takes to prepare for polyp removal
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Investigators

  • Principal Investigator: John J Guardiola, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data may be shared in the future upon request per PI discretion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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