Familial Adenomatous Polyposis Clinical Trial
— coldAPCOfficial title:
Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | March 2, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | polyp number | Significant reduction in the number of duodenal polyps at the next follow-up appointment | 12 months | |
Primary | polyp size | Significant reduction in the size of duodenal polyps at the next follow-up appointment | 12 months | |
Secondary | acute haematemesis | rate of acute adverse incidents: bleeding | 24 hours | |
Secondary | acute hemoglobin drop | rate of acute adverse incidents: Hb drop < 2g /dl (grammes per decilitre) | 24 hours | |
Secondary | acute severe hemoglobin drop | rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre) | 24 hours | |
Secondary | blood transfusion | rate of acute adverse incidents: Hb drop = or > 2g /dl (grammes per decilitre) | 24 hours | |
Secondary | endoscopic hemostasis | rate of acute adverse incidents: coagulation or clipping | 24 hours | |
Secondary | treatment of perforation | rate of acute adverse incidents: endoscopic clipping | 24 hours | |
Secondary | need for surgical intervention | rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment | 24 hours | |
Secondary | acute abdominal pain | rate of acute adverse incidents:pain | 24 hours | |
Secondary | acute dysphagia | rate of acute adverse incidents: stenosis | 24 hours | |
Secondary | acute rise of temperature | rate of acute adverse incidents: fever <38°C (degrees Centigrade) | 24 hours | |
Secondary | EGD (esophago-gastro-duodenoscopy) time | total EGD performing time | during EGD; up to 45 minutes | |
Secondary | therapy time | total ablation time in minutes | up to 30 minutes | |
Secondary | abdominal pain | abdominal pain assessed by patient survey | 4 days | |
Secondary | nausea | nausea assessed by patient survey | 4 days | |
Secondary | feeling of fullness | feeling of fullness assessed by patient survey | 4 days | |
Secondary | emesis | emesis assessed by patient survey | 4 days | |
Secondary | signs of bleeding | hematemesis or tar faeces assessed by patient survey | 4 days | |
Secondary | fever | fever >38°C | 4 days | |
Secondary | need for physician help | visits in doctor's office or hospital | 4 days | |
Secondary | success rate | Change in stage/number of points in Spigelman classification compared to the previous examination | 12 months | |
Secondary | dysphagia | dysphagia caused by duodenal stricture | 12 months | |
Secondary | balloon dilatations | need for endoscopic dilatation of strictured duodenum | 12 months | |
Secondary | abdominal pain | general abdominal pain assessed by patient survey | 12 months | |
Secondary | postprandial pain | postprandial abdominal pain assessed by patient survey | 12 months | |
Secondary | emesis | regurgitation due to duodenal strictures assessed by EGD | 12 months |
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