Using low-energy argon plasma to treat duodenal polyps in patients with Familial Adenomatous Polyposis
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
This study is testing a new way to treat precancerous duodenal polyps in people with Familial Adenomatous Polyposis using low-energy argon plasma to see if it can safely help manage these polyps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06435533 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using low-thermal argon plasma coagulation to treat precancerous duodenal polyps in patients with Familial Adenomatous Polyposis (FAP). FAP is a genetic disorder that leads to the formation of numerous colorectal polyps, increasing the risk of cancer. The study aims to apply a new argon plasma coagulation technique during routine endoscopic surveillance to effectively manage these polyps while minimizing thermal damage to the delicate duodenal wall. Participants will undergo treatment with a specific argon plasma device designed for this purpose.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with confirmed Familial Adenomatous Polyposis and duodenal polyposis who require follow-up endoscopy.
Not a fit: Patients with high-grade dysplasia, carcinoma, or other severe health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for managing duodenal polyps in FAP patients, potentially reducing their cancer risk.
How similar studies have performed: While the use of argon plasma coagulation has been successful in other medical fields, this specific application for duodenal polyps in FAP patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- University Hospital Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Thomas Rösch, Professor — Universitätskrankenhaus Hamburg-Eppendorf
- Study coordinator: Thomas Rösch, Professor
- Email: t.roesch@uke.de
- Phone: +49407410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.