Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

Not Applicable

• Conditions: Serrated Polyp; Colon Polyp; Colon Cancer; Colon Adenoma
• Interventions: Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR); Procedure: Cold Snare Piecemeal Resection (CSPR)

• Registration Number: NCT06462521
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-17
• Study Start: 2024-09-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 570

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold Snare Endoscopic Mucosal Resection (Cold EMR)	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.
Cold Snare Piecemeal Resection (CSPR)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Polyp Resection Time	1 day	The time it takes to remove the polyp completely
Resection Preparation Time	1 day	The time it takes to prepare for polyp removal
Total Procedure Time	1 day	The total time it takes to complete the colonoscopy procedure
Adverse Events	30 Days	The number of complications for each randomization arm during and after the procedure
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

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States