White River Junction VAMC
White River Junction, Vermont, 05009, United States
NCT Number: NCT03865537
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
White River Junction, Vermont, 05009, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will have their large polyp removed without electrocautery
Participants will have their large polyp removed with electrocautery
Participants will have their polyp submucosally injected with Eleview
Participants will have their polyp submucosally injected with placebo
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
Time frame: during the procedure and up to 30 days following the procedure
Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Time frame: immediately following polyp resection during the colonoscopy
Injection performance
Time frame: immediately following polyp resection during the colonoscopy
volume of injection
Time frame: immediately following polyp resection during the colonoscopy
Sidney index
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.
Time frame: at the time of polyp resection
bleeding that requires endoscopic intervention to stop the bleeding
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
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
White River Junction Veterans Affairs Medical Center
Fed
Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial
Acronym: LPS-II
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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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