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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Polyps; Polyps of Colon; Polyp Intestine
• Intervention / Treatment: Procedure: cold snare endoscopic mucosal resection (C-EMR); Procedure: Hot snare endoscopic mucosal resection (H-EMR)

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 Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krithi Krishna Koduri, MD; Phone Number: 91 9870083545; Email: drkrithivk@gmail.com
• Study Contact Backup: Name: Nitin Jagtap, MD; Phone Number: 91 9182859523; Email: Docnits13@gmail.com

Study Locations

• India
  • Telanagana
    • Hyderabad, Telanagana, India, 500082
      • Recruiting
      • Krithi Krishna Koduri
      • Contact: Nitin Jagtap, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.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.	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.
Sham Comparator: 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.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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Krithi Krishna Koduri, MD, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 21, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: C-EMR VS H-EMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No