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

Asian Institute of Gastroenterology, India

Status: Enrolling

Conditions: Polyps; Polyps of Colon; Polyp Intestine

Treatments: Procedure: Hot snare endoscopic mucosal resection (H-EMR); Procedure: cold snare endoscopic mucosal resection (C-EMR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06180798

C-EMR VS H-EMR

Details and patient eligibility

About

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

Full 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

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

cold snare endoscopic mucosal resection (C-EMR)

Active Comparator group

Description:

All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.

Treatment:

Procedure: cold snare endoscopic mucosal resection (C-EMR)

Hot snare endoscopic mucosal resection (H-EMR)

Sham Comparator group

Description:

All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.

Treatment:

Procedure: Hot snare endoscopic mucosal resection (H-EMR)