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Cold Snare Endoscopic Mucosal Resection Trial (LPS-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865537
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : June 1, 2021
Sponsor:
Collaborators:
Dartmouth College
US Endoscopy
Aries Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : October 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Severe Adverse Events [ Time Frame: 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 :
  1. Subcategories of severe adverse events [ Time Frame: during the procedure and up to 30 days following the procedure ]
    Bleeding, post-polypectomy syndrome, perforation, abdominal pain

  2. Performance submucosal injectate [ Time Frame: immediately following polyp resection during the colonoscopy ]
    Injection performance

  3. Volume of submucosal injectate [ Time Frame: immediately following polyp resection during the colonoscopy ]
    volume of injection

  4. Efficacy of submucosal injectate [ Time Frame: immediately following polyp resection during the colonoscopy ]
    Sidney index

  5. Completeness of polyp resection [ Time Frame: 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.

  6. Intraprocedural bleeding [ Time Frame: at the time of polyp resection ]
    bleeding that requires endoscopic intervention to stop the bleeding

  7. Polyp recurrence [ Time Frame: 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

  8. Crossover from cold to hot snare [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865537


Contacts
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Contact: Heiko Pohl, MD 8022959363 heiko.pohl@dartmouth.edu
Contact: Andres H Aguilera-Fish, MD 8022959363 ext 6123 andres.aguilera-fish@va.gov

Locations
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United States, Vermont
White River Junction VAMC Recruiting
White River Junction, Vermont, United States, 05009
Contact: Heiko Pohl, MD    802-295-9363 ext 5595    heiko.pohl@dartmouth.edu   
Contact: Andres H Aguilera-Fish, MD    8022959363 ext 6123    andres.aguilera-fish@va.gov   
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
Dartmouth College
US Endoscopy
Aries Pharmaceuticals, Inc.
Investigators
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Study Chair: Heiko Pohl, MD White River Junction VAMC, Geisel School of Medicine at Dartmouth
More Information
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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: March 7, 2019    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Polyps
Colonic Polyps
Disease Attributes
 Pathologic Processes
Pathological Conditions, Anatomical
Intestinal Polyps