Cold Snare Endoscopic Mucosal Resection Trial (LPS-II)

Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Colonic Polyp; Colonoscopy; Complication
• Intervention / Treatment: Procedure: Cold snare EMR; Procedure: Eleview injection; Procedure: Placebo injection; Procedure: Hot snare EMR

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 Type: Interventional
• Enrollment (Anticipated): 870
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heiko Pohl, MD; Phone Number: 8022959363; Email: heiko.pohl@dartmouth.edu
• Study Contact Backup: Name: Andres H Aguilera-Fish, MD; Phone Number: 6123 8022959363; Email: andres.aguilera-fish@va.gov

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • Recruiting
      • White River Junction VAMC
      • Contact: Andres H Aguilera-Fish, MD; Phone Number: 6123 8022959363; Email: andres.aguilera-fish@va.gov
      • Contact: Heiko Pohl, MD; Phone Number: 5595 802-295-9363; Email: heiko.pohl@dartmouth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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: Eleview injection; Participants will have their polyp submucosally injected with Eleview; Procedure: Hot snare EMR; Participants will have their large polyp removed with electrocautery
Active Comparator: Hot snare & Placebo injection; Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo	Procedure: Placebo injection; Participants will have their polyp submucosally injected with placebo; Procedure: Hot snare EMR; Participants will have their large polyp removed with electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcategories of severe adverse events	Bleeding, post-polypectomy syndrome, perforation, abdominal pain	during the procedure and up to 30 days following the procedure
Performance submucosal injectate	Injection performance	immediately following polyp resection during the colonoscopy
Volume of submucosal injectate	volume of injection	immediately following polyp resection during the colonoscopy
Efficacy of submucosal injectate	Sidney index	immediately following polyp resection during the colonoscopy
Completeness of polyp resection	Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.	immediately following polyp resection during the colonoscopy
Intraprocedural bleeding	bleeding that requires endoscopic intervention to stop the bleeding	at the time of polyp resection
Polyp recurrence	Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection	at surveillance colonoscopies up to 5 years following the initial polyp resection
Crossover from cold to hot snare	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	at the time of polyp resection

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: Dartmouth College; US Endoscopy; Aries Pharmaceuticals, Inc.
• Investigators: Study Chair: Heiko Pohl, MD, White River Junction VAMC, Geisel School of Medicine at Dartmouth

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): April 1, 2027

Study Registration Dates

• First Submitted: March 3, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Intestinal Polyps; Recurrence; Polyps; Colonic Polyps
• Other Study ID Numbers: 119681

Drug and device information, study documents

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