Cold Snare Endoscopic Mucosal Resection Trial (LPS-II)
Primary Purpose
Colonic Polyp, Colonoscopy, Complication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold snare EMR
Hot snare EMR
Eleview injection
Placebo injection
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyp
Eligibility Criteria
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
Sites / Locations
- White River Junction VAMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Cold snare & Eleview injection
Cold Snare & Placebo injection
Hot snare & Eleview injection
Hot snare & Placebo injection
Arm Description
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Subcategories of severe adverse events
Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Performance submucosal injectate
Injection performance
Volume of submucosal injectate
volume of injection
Efficacy of submucosal injectate
Sidney index
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.
Intraprocedural bleeding
bleeding that requires endoscopic intervention to stop the bleeding
Polyp recurrence
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
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
Full Information
NCT ID
NCT03865537
First Posted
March 3, 2019
Last Updated
May 28, 2021
Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
Dartmouth College, US Endoscopy, Aries Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03865537
Brief Title
Cold Snare Endoscopic Mucosal Resection Trial
Acronym
LPS-II
Official Title
Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
Dartmouth College, US Endoscopy, Aries Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colonoscopy, Complication, Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above
Allocation
Randomized
Enrollment
870 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold snare & Eleview injection
Arm Type
Experimental
Arm Description
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
Arm Title
Cold Snare & Placebo injection
Arm Type
Experimental
Arm Description
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
Arm Title
Hot snare & Eleview injection
Arm Type
Active Comparator
Arm Description
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
Arm Title
Hot snare & Placebo injection
Arm Type
Active Comparator
Arm Description
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
Intervention Type
Procedure
Intervention Name(s)
Cold snare EMR
Intervention Description
Participants will have their large polyp removed without electrocautery
Intervention Type
Procedure
Intervention Name(s)
Hot snare EMR
Intervention Description
Participants will have their large polyp removed with electrocautery
Intervention Type
Procedure
Intervention Name(s)
Eleview injection
Intervention Description
Participants will have their polyp submucosally injected with Eleview
Intervention Type
Procedure
Intervention Name(s)
Placebo injection
Intervention Description
Participants will have their polyp submucosally injected with placebo
Primary Outcome Measure Information:
Title
Severe Adverse Events
Description
Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure
Time Frame
up to 30 days following the procedure
Secondary Outcome Measure Information:
Title
Subcategories of severe adverse events
Description
Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Time Frame
during the procedure and up to 30 days following the procedure
Title
Performance submucosal injectate
Description
Injection performance
Time Frame
immediately following polyp resection during the colonoscopy
Title
Volume of submucosal injectate
Description
volume of injection
Time Frame
immediately following polyp resection during the colonoscopy
Title
Efficacy of submucosal injectate
Description
Sidney index
Time Frame
immediately following polyp resection during the colonoscopy
Title
Completeness of polyp resection
Description
Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.
Time Frame
immediately following polyp resection during the colonoscopy
Title
Intraprocedural bleeding
Description
bleeding that requires endoscopic intervention to stop the bleeding
Time Frame
at the time of polyp resection
Title
Polyp recurrence
Description
Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection
Time Frame
at surveillance colonoscopies up to 5 years following the initial polyp resection
Title
Crossover from cold to hot snare
Description
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
Time Frame
at the time of polyp resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heiko Pohl, MD
Phone
8022959363
Email
heiko.pohl@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andres H Aguilera-Fish, MD
Phone
8022959363
Ext
6123
Email
andres.aguilera-fish@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko Pohl, MD
Organizational Affiliation
White River Junction VAMC, Geisel School of Medicine at Dartmouth
Official's Role
Study Chair
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heiko Pohl, MD
Phone
802-295-9363
Ext
5595
Email
heiko.pohl@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Andres H Aguilera-Fish, MD
Phone
8022959363
Ext
6123
Email
andres.aguilera-fish@va.gov
12. IPD Sharing Statement
Learn more about this trial
Cold Snare Endoscopic Mucosal Resection Trial
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