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

Not Applicable

Recruiting

• Conditions: Familial Adenomatous Polyposis; Duodenal Adenoma; Adenomatous Polyposis Coli
• Interventions: Device: low energy argonplasma coagulation

• Registration Number: NCT06435533
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed 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 Timeline

• Study Start: 2023-12-06
• Study First Submitted: 2024-03-14
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-01-30
• Study Completion: 2025-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
duodenal polyps <10 mm	low energy argonplasma coagulation	low energy argonplasma coagulation

Primary Outcome Measures

Name	Time	Method
polyp size	12 months	Significant reduction in the size of duodenal polyps at the next follow-up appointment
polyp number	12 months	Significant reduction in the number of duodenal polyps at the next follow-up appointment

Secondary Outcome Measures

Name	Time	Method
success rate	12 months	Change in stage/number of points in Spigelman classification compared to the previous examination
balloon dilatations	12 months	need for endoscopic dilatation of strictured duodenum
signs of bleeding	4 days	hematemesis or tar faeces assessed by patient survey
fever	4 days	fever \>38°C
dysphagia	12 months	dysphagia caused by duodenal stricture
need for surgical intervention	24 hours	rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment
acute dysphagia	24 hours	rate of acute adverse incidents: stenosis
nausea	4 days	nausea assessed by patient survey
acute haematemesis	24 hours	rate of acute adverse incidents: bleeding
acute severe hemoglobin drop	24 hours	rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
blood transfusion	24 hours	rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
acute abdominal pain	24 hours	rate of acute adverse incidents:pain
acute rise of temperature	24 hours	rate of acute adverse incidents: fever \<38°C (degrees Centigrade)
EGD (esophago-gastro-duodenoscopy) time	during EGD; up to 45 minutes	total EGD performing time
therapy time	up to 30 minutes	total ablation time in minutes
abdominal pain	12 months	general abdominal pain assessed by patient survey
acute hemoglobin drop	24 hours	rate of acute adverse incidents: Hb drop \< 2g /dl (grammes per decilitre)
endoscopic hemostasis	24 hours	rate of acute adverse incidents: coagulation or clipping
treatment of perforation	24 hours	rate of acute adverse incidents: endoscopic clipping
postprandial pain	12 months	postprandial abdominal pain assessed by patient survey
feeling of fullness	4 days	feeling of fullness assessed by patient survey
emesis	12 months	regurgitation due to duodenal strictures assessed by EGD
need for physician help	4 days	visits in doctor's office or hospital

Trial Locations

Locations (1)

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany