Adenomatous Polyposis Coli, Duodenal Adenoma, Familial Adenomatous Polyposis
Conditions
Keywords
Familial Adenomatous Polyposis, FAP, duodenal adenoma, argon plasma coagulation, Spigelman classification stage III
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.
Interventions
DEVICElow energy argonplasma coagulation
see above
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| polyp number | 12 months | Significant reduction in the number of duodenal polyps at the next follow-up appointment |
| polyp size | 12 months | Significant reduction in the size of duodenal polyps at the next follow-up appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| endoscopic hemostasis | 24 hours | rate of acute adverse incidents: coagulation or clipping |
| treatment of perforation | 24 hours | rate of acute adverse incidents: endoscopic clipping |
| need for surgical intervention | 24 hours | rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment |
| acute abdominal pain | 24 hours | rate of acute adverse incidents:pain |
| acute dysphagia | 24 hours | rate of acute adverse incidents: stenosis |
| 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 |
| acute haematemesis | 24 hours | rate of acute adverse incidents: bleeding |
| nausea | 4 days | nausea assessed by patient survey |
| feeling of fullness | 4 days | feeling of fullness assessed by patient survey |
| emesis | 4 days | emesis assessed by patient survey |
| signs of bleeding | 4 days | hematemesis or tar faeces assessed by patient survey |
| fever | 4 days | fever \>38°C |
| need for physician help | 4 days | visits in doctor's office or hospital |
| success rate | 12 months | Change in stage/number of points in Spigelman classification compared to the previous examination |
| dysphagia | 12 months | dysphagia caused by duodenal stricture |
| balloon dilatations | 12 months | need for endoscopic dilatation of strictured duodenum |
| postprandial pain | 12 months | postprandial abdominal pain assessed by patient survey |
| abdominal pain | 4 days | abdominal pain assessed by patient survey |
| acute hemoglobin drop | 24 hours | rate of acute adverse incidents: Hb drop \< 2g /dl (grammes per decilitre) |
Countries
Germany
Contacts
Primary ContactThomas Rösch, Professor
Backup ContactTania Ruppenthal
Outcome results
None listed