Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Not Applicable

Recruiting

• Conditions: Endoscopic Mucosal Resection; Polyp of Colon

• Registration Number: NCT06937671
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps.

Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• Adult patient (age 18 years or older)
• Polyp size of at least 20 mm
• • Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)

Exclusion Criteria

• Polyps with previous failed resection attempts or polyp recurrence
• Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
• Polyps with nodules too large (>1-1.5cm) for the use of a cold snare
• Inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence of polyps	3-6 months after the procedure	Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy

Secondary Outcome Measures

Name	Time	Method
Adverse events	3-6 months after the procedure	Composite of clinically important adverse events: (1) Perforation requiring hospitalization or surgery (2) Bleeding associated with at least 2-gram Hb drop or hospitalization or Intervention (3) Post-polypectomy syndrome requiring hospital admission
Polyp recurrence rates	3-6 months after EMR procedure	Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Cost benefit analysis	3-6 months after the procedure	- Cost-benefit analysis includes the costs of additional hospitalizations related to post-procedure complications and the cost of additional colonoscopies required to follow up treatment of recurrence. Costs will be calculated from a Medicare perspective.
Subgroup polyp recurrence rate	3-6 months after the procedure	- Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation

Trial Locations

Locations (2)

Cleveland Clinic Weston; 🇺🇸 Weston, Florida, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States