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

Last updated: January 28, 2024
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Colon Polyps

Treatment

Hot snare endoscopic mucosal resection (H-EMR)

cold snare endoscopic mucosal resection (C-EMR)

Clinical Study ID

NCT06180798
C-EMR VS H-EMR
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Hot snare endoscopic mucosal resection (H-EMR)
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
December 30, 2024

Study 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

Connect with a study center

  • Krithi Krishna Koduri

    Hyderabad, Telanagana 500082
    India

    Active - Recruiting

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