Cold Snare Endoscopic Mucosal Resection Trial

  • STATUS
    Recruiting
  • End date
    Apr 1, 2027
  • participants needed
    870
  • sponsor
    White River Junction Veterans Affairs Medical Center
Updated on 10 June 2021
cold
polypectomy
colonoscopy
colorectal polyps
mucosal resection

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.

Details
Condition complications medical, relapse/recurrence, Medical Complication, colonoscopy, Relapse, Complication, COLONIC POLYP, Colon Polyps
Treatment Placebo Injection, Cold snare EMR, Hot snare EMR, Eleview injection
Clinical Study IdentifierNCT03865537
SponsorWhite River Junction Veterans Affairs Medical Center
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note