Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- polyp size
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
polyp size
Time Frame: 12 months
Significant reduction in the size of duodenal polyps at the next follow-up appointment
polyp number
Time Frame: 12 months
Significant reduction in the number of duodenal polyps at the next follow-up appointment
Secondary Outcomes
- success rate(12 months)
- balloon dilatations(12 months)
- need for surgical intervention(24 hours)
- acute dysphagia(24 hours)
- nausea(4 days)
- signs of bleeding(4 days)
- fever(4 days)
- dysphagia(12 months)
- acute haematemesis(24 hours)
- acute severe hemoglobin drop(24 hours)
- blood transfusion(24 hours)
- acute abdominal pain(24 hours)
- acute rise of temperature(24 hours)
- EGD (esophago-gastro-duodenoscopy) time(during EGD; up to 45 minutes)
- therapy time(up to 30 minutes)
- abdominal pain(12 months)
- acute hemoglobin drop(24 hours)
- endoscopic hemostasis(24 hours)
- treatment of perforation(24 hours)
- postprandial pain(12 months)
- feeling of fullness(4 days)
- emesis(12 months)
- need for physician help(4 days)
Investigators
Prof. Dr. Thomas Rösch
Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf