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

NCT06180798 | Unknown

• 1 other identifier: C-EMR VS H-EMR
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Polyps of Colon; Polyps; Polyp Intestine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes include procedure time, cost and adverse events.

  1 YEAR

Study Arms (2)

cold snare endoscopic mucosal resection (C-EMR)

ACTIVE COMPARATOR

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)

Hot snare endoscopic mucosal resection (H-EMR)

SHAM COMPARATOR

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)

Interventions

cold snare endoscopic mucosal resection (C-EMR) PROCEDURE

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.

cold snare endoscopic mucosal resection (C-EMR)

Hot snare endoscopic mucosal resection (H-EMR) PROCEDURE

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.

Hot snare endoscopic mucosal resection (H-EMR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Krithi Krishna Koduri

Hyderabad, Telanagana, 500082, India

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Polyps; Intestinal Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Krithi Krishna Koduri, MD

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krithi Krishna Koduri, MD

CONTACT

9870083545; drkrithivk@gmail.com

Nitin Jagtap, MD

CONTACT

9182859523; Docnits13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be randomised to C-EMR and H-EMR by a computer generated sequence provided in turn by the research assistant. The patient, pathologist and statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center randomized controlled study with two parallel groups with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: December 26, 2023
• Study Start: January 10, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)