PULSed Field ablAtion of coloRectal Polyps

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called pulsed field ablation (PFA) to remove colorectal polyps, which are growths in the colon that can sometimes lead to cancer. The researchers want to find out if this method is safe and effective. They will look at how well the treatment works, how long it takes, and whether patients are satisfied with the results. The trial is not yet recruiting participants, but it’s aiming to include adults aged 18 and older who have at least one polyp measuring more than 5mm in a specific part of the colon.

To be eligible for the trial, participants must be able to understand the study and give their written consent. They should have a polyp that fits certain criteria and must not have any complex or high-risk polyps. During the study, participants can expect to undergo the PFA treatment and have their progress monitored to ensure safety and effectiveness. It's an important step in exploring new ways to manage colorectal polyps and improve patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \> 18 years of age.
• • Ability to review the consent form prior to enrolment into the study • Patients must be mentally capable of understanding the information given • Patients must give written informed consent prior to undergoing any study-specific procedures.
• • Patients must have at least one polyp (treatment naive, recurrent or residual) measuring \>5mm, located distal to the splenic flexure(i.e descending colon, Sigmoid colon, recto sigmoid junction and the rectum above the dentate line)
• • Polyp(s) must be classified as Type 1 or Type 2, based on NICE (Narrow Band Imaging International Colorectal Endoscopic) classification; OR Type 1 or Type 2A based on JNET (Japan Narrow Band Imaging Expert Team) classification
• • Patients must have a World Health Organization (WHO) performance status ≤ 2 . Patients must have a life expectancy of at least 6 months
• Exclusion Criteria:
• • \< 18 years of age.
• • Patients who are incapacitated, unconscious or from a vulnerable population. • Patient who is pregnant or breastfeeding
• • Patients unable to provide their own informed consent
• • Patients with complex / challenging polyp(s), including but not limited to those that are: o \>20mm in size o Flat/bulky in shape o Extending beyond 2 haustra folds or occupying more than 1/3rd of the lumenal circumference o Located on the right colon proximal to the splenic flexure, ileocecal valve, hepatic and splenic flexure or dentate line of the rectum o Fibrosis from large lateral spreading lesions
• • Patients with NICE Type 3 category polyps, OR JNET Type 2B or Type 3 polyps
• • Patients with British Society of Gastroenterology (BSG) category C (high risk polyps).
• • Five or more polyps in a single patient
• • Grossly inflamed colonic mucosa with bleeding or ulcers
• • Implanted colonic stents
• • Polyposis syndromes