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

Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180798
• Other study ID #: C-EMR VS H-EMR
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Asian Institute of Gastroenterology, India
• Contact: Krithi Krishna Koduri, MD
• Phone: 9870083545
• Email: drkrithivk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyps
• Polyps
• Polyps of Colon

Intervention

Procedure:
• cold snare endoscopic mucosal resection (C-EMR)
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. 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 . 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.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps. Bleeding will be assessed for 2 mins to decide upon requirement of immediate hemostatic methods in the form of clipping or electrocoagulation.
• Hot snare endoscopic mucosal resection (H-EMR)
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. 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.submucosal injection of saline mixed with methylene blue will be used.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group. After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.

Locations

Country	Name	City	State
India	Krithi Krishna Koduri	Hyderabad	Telanagana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the complete resection rate	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.	1 YEAR
Secondary	Secondary outcomes include procedure time, cost and adverse events.	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.	1 YEAR