Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients. In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage. The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma. Regarding current knowledge this is the first application of this APC modality in the GI tract. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06435533
Study type	Interventional
Source	Universitätsklinikum Hamburg-Eppendorf
Contact	Thomas Rösch, Professor
Phone	+49407410
Email	t.roesch@uke.de
Status	Recruiting
Phase	N/A
Start date	December 6, 2023
Completion date	March 2, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms