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

Indiana University

Status: Invitation-only

Conditions: Colon Cancer; Serrated Polyp; Colon Adenoma; Colon Polyp

Treatments: Procedure: Cold Snare Piecemeal Resection (CSPR); Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06462521

20831

Details and patient eligibility

About

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.

Enrollment: 570 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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570 participants in 2 patient groups

Cold Snare Piecemeal Resection (CSPR)

Experimental group

Description:

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.

Treatment:

Procedure: Cold Snare Piecemeal Resection (CSPR)

Cold Snare Endoscopic Mucosal Resection (Cold EMR)

Experimental group

Description:

Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.

Treatment:

Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR)