Cold Snare Endoscopic Mucosal Resection Trial

Colonoscopy Clinical Trial

— LPS-II  

Official title:

Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865537
• Other study ID #: 119681
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2021
• Source: White River Junction Veterans Affairs Medical Center
• Contact: Heiko Pohl, MD
• Phone: 8022959363
• Email: heiko.pohl[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 870
• Est. completion date: April 1, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colonoscopy
• Complication
• Polyps
• Recurrence

Intervention

Procedure:
• Cold snare EMR
Participants will have their large polyp removed without electrocautery
• Hot snare EMR
Participants will have their large polyp removed with electrocautery
• Eleview injection
Participants will have their polyp submucosally injected with Eleview
• Placebo injection
Participants will have their polyp submucosally injected with placebo

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (4)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center	Aries Pharmaceuticals, Inc., Dartmouth College, US Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subcategories of severe adverse events	Bleeding, post-polypectomy syndrome, perforation, abdominal pain	during the procedure and up to 30 days following the procedure
Secondary	Performance submucosal injectate	Injection performance	immediately following polyp resection during the colonoscopy
Secondary	Volume of submucosal injectate	volume of injection	immediately following polyp resection during the colonoscopy
Secondary	Efficacy of submucosal injectate	Sidney index	immediately following polyp resection during the colonoscopy
Secondary	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
Secondary	Intraprocedural bleeding	bleeding that requires endoscopic intervention to stop the bleeding	at the time of polyp resection
Secondary	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
Secondary	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