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Active, Not Recruiting

NCT Number: NCT03865537

Cold Snare Endoscopic Mucosal Resection 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

White River Junction VAMC

White River Junction, Vermont, 05009, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold snare EMR

Procedure

Participants will have their large polyp removed without electrocautery

Hot snare EMR

Procedure

Participants will have their large polyp removed with electrocautery

Eleview injection

Procedure

Participants will have their polyp submucosally injected with Eleview

placebo injection

Procedure

Participants will have their polyp submucosally injected with placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • Cosmo Pharmaceuticals
  • Dartmouth College
  • Steris

Registry information

Official study title

Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

Acronym: LPS-II

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Mar 7, 2019
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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