LPS-II: Cold Snare Endoscopic Mucosal Resection Trial

Sponsor

White River Junction Veterans Affairs Medical Center (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT03865537

Collaborator

Dartmouth College (Other), US Endoscopy (Industry), Aries Pharmaceuticals, Inc. (Other)

870

Enrollment

Location

Arms

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp Colonoscopy Complication Recurrence	Procedure: Cold snare EMR Procedure: Hot snare EMR Procedure: Eleview injection Procedure: Placebo injection	N/A

Detailed Description

Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection.

Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

870 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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).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).

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above

Primary Purpose:

Treatment

Official Title:

Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cold snare & Eleview injection Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview	Procedure: Cold snare EMR Participants will have their large polyp removed without electrocautery Procedure: Eleview injection Participants will have their polyp submucosally injected with Eleview
Experimental: Cold Snare & Placebo injection Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo	Procedure: Cold snare EMR Participants will have their large polyp removed without electrocautery Procedure: Placebo injection Participants will have their polyp submucosally injected with placebo
Active Comparator: Hot snare & Eleview injection Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview	Procedure: Hot snare EMR Participants will have their large polyp removed with electrocautery Procedure: Eleview injection Participants will have their polyp submucosally injected with Eleview
Active Comparator: Hot snare & Placebo injection Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo	Procedure: Hot snare EMR Participants will have their large polyp removed with electrocautery Procedure: Placebo injection Participants will have their polyp submucosally injected with placebo

Outcome Measures

Primary Outcome Measures

Severe Adverse Events [up to 30 days following the procedure]
Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure

Secondary Outcome Measures

Subcategories of severe adverse events [during the procedure and up to 30 days following the procedure]
Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Performance submucosal injectate [immediately following polyp resection during the colonoscopy]
Injection performance
Volume of submucosal injectate [immediately following polyp resection during the colonoscopy]
volume of injection
Efficacy of submucosal injectate [immediately following polyp resection during the colonoscopy]
Sidney index
Completeness of polyp resection [immediately following polyp resection during the colonoscopy]
Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.
Intraprocedural bleeding [at the time of polyp resection]
bleeding that requires endoscopic intervention to stop the bleeding
Polyp recurrence [at surveillance colonoscopies up to 5 years following the initial polyp resection]
Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection
Crossover from cold to hot snare [at the time of polyp resection]
Proportion of polyps in the cold snare group that could not be removed by cold snare and were removed by hot snare, categorized by size and morphology subtypes of polyps

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
Patients with a ≥20mm non-pedunculated colorectal polyp

Exclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	White River Junction VAMC	White River Junction	Vermont	United States	05009

Sponsors and Collaborators

White River Junction Veterans Affairs Medical Center
Dartmouth College
US Endoscopy
Aries Pharmaceuticals, Inc.

Investigators

Study Chair: Heiko Pohl, MD, White River Junction VAMC, Geisel School of Medicine at Dartmouth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Heiko Pohl, Associate Professor or Medicine, White River Junction Veterans Affairs Medical Center

ClinicalTrials.gov Identifier:

NCT03865537

Other Study ID Numbers:

119681

First Posted:

Mar 7, 2019

Last Update Posted:

Jun 1, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Polyps

Colonic Polyps

Study Results

No Results Posted as of Jun 1, 2021