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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
see above
University Hospital Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGpolyp number
Significant reduction in the number of duodenal polyps at the next follow-up appointment
Time frame: 12 months
polyp size
Significant reduction in the size of duodenal polyps at the next follow-up appointment
Time frame: 12 months
acute haematemesis
rate of acute adverse incidents: bleeding
Time frame: 24 hours
acute hemoglobin drop
rate of acute adverse incidents: Hb drop \< 2g /dl (grammes per decilitre)
Time frame: 24 hours
acute severe hemoglobin drop
rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
Time frame: 24 hours
blood transfusion
rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
Time frame: 24 hours
endoscopic hemostasis
rate of acute adverse incidents: coagulation or clipping
Time frame: 24 hours
treatment of perforation
rate of acute adverse incidents: endoscopic clipping
Time frame: 24 hours
need for surgical intervention
rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment
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Time frame: 24 hours
acute abdominal pain
rate of acute adverse incidents:pain
Time frame: 24 hours
acute dysphagia
rate of acute adverse incidents: stenosis
Time frame: 24 hours
acute rise of temperature
rate of acute adverse incidents: fever \<38°C (degrees Centigrade)
Time frame: 24 hours
EGD (esophago-gastro-duodenoscopy) time
total EGD performing time
Time frame: during EGD; up to 45 minutes
therapy time
total ablation time in minutes
Time frame: up to 30 minutes
abdominal pain
abdominal pain assessed by patient survey
Time frame: 4 days
nausea
nausea assessed by patient survey
Time frame: 4 days
feeling of fullness
feeling of fullness assessed by patient survey
Time frame: 4 days
emesis
emesis assessed by patient survey
Time frame: 4 days
signs of bleeding
hematemesis or tar faeces assessed by patient survey
Time frame: 4 days
fever
fever \>38°C
Time frame: 4 days
need for physician help
visits in doctor's office or hospital
Time frame: 4 days
success rate
Change in stage/number of points in Spigelman classification compared to the previous examination
Time frame: 12 months
dysphagia
dysphagia caused by duodenal stricture
Time frame: 12 months
balloon dilatations
need for endoscopic dilatation of strictured duodenum
Time frame: 12 months
abdominal pain
general abdominal pain assessed by patient survey
Time frame: 12 months
postprandial pain
postprandial abdominal pain assessed by patient survey
Time frame: 12 months
emesis
regurgitation due to duodenal strictures assessed by EGD
Time frame: 12 months