Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm)

Not Applicable

Recruiting

• Conditions: Polyp Intestine; Polyps of Colon; Polyps

• Registration Number: NCT06180798
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief Summary

OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.

DESIGN : A Randomised interventional study. Sample size: 330

Detailed Description

* This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.

* In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.

* After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.

* A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps

Study Timeline

• Study First Submitted: 2023-10-21
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2023-12-26
• Status Verified: 2024-01
• Study Start: 2024-01-10
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Adult above 18 years
• polyp size greater than 5-10mm.

Exclusion Criteria

• Inflammatory bowel disease
• Familial Polyposis Syndromes
• Patient who is unable to understand study protocol or not consenting
• Severe coagulopathy (INR Greater than 1.5 platelets)
• Receiving antiplatelets withing 5 days of procedure
• If antiplatelets stopped for 5 days-they were restarted on next day after procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess the complete resection rate	1 YEAR	Primary outcome will be tested with chi-square test or Fisher's exact test. The level of significance has been set at 5%. To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include procedure time, cost and adverse events.	1 YEAR	Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence. Kaplan-Meier survival analysis will be done for appearance clinical recurrence.

Trial Locations

Locations (1)

Krithi Krishna Koduri; 🇮🇳 Hyderabad, Telanagana, India