Cold Snare Endoscopic Mucosal Resection Trial

NCT03865537 | Active Not Recruiting DMC

• 1 other identifier: 119681
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (≥20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.

Conditions

Colonic Polyp; Colonoscopy; Complication; Recurrence

Outcome Measures

Primary Outcomes (1)

• Severe Adverse Events

  Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure

  up to 30 days following the procedure

Secondary Outcomes (8)

• Subcategories of severe adverse events

  during the procedure and up to 30 days following the procedure

• Performance submucosal injectate

  immediately following polyp resection during the colonoscopy

• Volume of submucosal injectate

  immediately following polyp resection during the colonoscopy

• Efficacy of submucosal injectate

  immediately following polyp resection during the colonoscopy

• Completeness of polyp resection

  immediately following polyp resection during the colonoscopy

Study Arms (4)

Cold snare & Eleview injection

EXPERIMENTAL

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview

Procedure: Cold snare EMR; Procedure: Eleview injection

Cold Snare & Placebo injection

EXPERIMENTAL

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo

Procedure: Cold snare EMR; Procedure: Placebo injection

Hot snare & Eleview injection

ACTIVE COMPARATOR

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview

Procedure: Hot snare EMR; Procedure: Eleview injection

Hot snare & Placebo injection

ACTIVE COMPARATOR

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo

Procedure: Hot snare EMR; Procedure: Placebo injection

Interventions

Cold snare EMR PROCEDURE

Participants will have their large polyp removed without electrocautery

Cold Snare & Placebo injection; Cold snare & Eleview injection

Hot snare EMR PROCEDURE

Participants will have their large polyp removed with electrocautery

Hot snare & Eleview injection; Hot snare & Placebo injection

Eleview injection PROCEDURE

Participants will have their polyp submucosally injected with Eleview

Cold snare & Eleview injection; Hot snare & Eleview injection

Placebo injection PROCEDURE

Participants will have their polyp submucosally injected with placebo

Cold Snare & Placebo injection; Hot snare & Placebo injection

Eligibility Criteria

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

You may qualify if:

• Patients with a ≥20mm non-pedunculated colorectal polyp

You may not qualify if:

• Pedunculated polyps (as defined by Paris Classification type Ip)
• Suspected adenocarcinoma with deep submucosal invasion
• Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
• Patients with inflammatory bowel disease
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class\>3)
• Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
• Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
• Pregnancy

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• Dartmouth College: collaborator
• Steris: collaborator
• Cosmo Pharmaceuticals: collaborator

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

Related Publications (1)

• Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075.

  PMID: 40393701 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Recurrence

Interventions

SIC-8000

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Heiko Pohl, MD

  White River Junction VAMC, Geisel School of Medicine at Dartmouth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor or Medicine

Model Details: 2 x 2 randomized trial. First randomization: Among half of patients with a large polyp will be removed by electrocautery ("hot") snare resection, and the other half will have their polyp removed by snare resection without electrocautery ("cold"). Second randomization: Among half of patients the large polyp will by lifted (submucosal injection before resection) with Eleview; among the other by Placebo (Normal Saline with Methylene Blue).

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 7, 2019
• Study Start: October 1, 2019
• Primary Completion: May 31, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (1)