Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method using cold atmospheric plasma to remove precancerous polyps in the duodenum (the first part of the small intestine) in patients with Familial Adenomatous Polyposis (FAP). FAP is a genetic condition that leads to the formation of many polyps, which can become cancerous over time. The goal of this study is to see if this low-thermal plasma technique is a safe and effective way to treat these polyps, particularly those that are less than 10 mm in size.

To participate in this trial, individuals must have a confirmed diagnosis of FAP and a specific type of polyp that requires monitoring within a year. Eligible participants are typically between the ages of 65 and 74 or 29 and 219. However, those with certain health issues, such as severe illness or pregnancy, are not eligible. Participants can expect to undergo the new treatment and will be monitored for safety and effectiveness. This study is currently recruiting participants, and those who join will contribute to important research that could improve how we manage polyps in patients with FAP.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • confirmed FAP disease
• • duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
• • presence of duodenal polyps \< 10 mm
• • written Informed Consent
• Exclusion Criteria:
• • presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
• • pregnancy or breastfeeding
• • severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year
• • severe coagulopathy
• • any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas