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Recruiting NCT06435533

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

Trial Parameters

Condition Adenomatous Polyposis Coli
Sponsor Universitätsklinikum Hamburg-Eppendorf
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-12-06
Completion 2025-01-30
Interventions
low energy argonplasma coagulation

Brief Summary

The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.

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

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