Cap Assisted Upper Endoscopy versus side viewing endoscopy for examination ofthe Major Duodenal Papilla in patients with familial adenomatous polyposis: A Randomized, Blinded, Controlled Crossover Study (CAPFAP Study)
- Conditions
- familial adenomatous polyposis
- Registration Number
- DRKS00024869
- Lead Sponsor
- Rheinische Friedrich-Wilhelms-Universität Bonnvertreten durch die Medizinische Fakultät der Universität Bonnvertreten durch den Dekan der Medizinischen FakultätVenusberg-Campus 153127 Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
Age =18 years
- Written informed consent of the subject for voluntary participation in the study.
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits
Indication-specific inclusion criteria:
Proven presence of a pathogenic germline variant in the APC-gene (familial adenomatous polyposis)
- Subject unable to understand the nature, scope, significance and consequences of this clinical trial
- Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical trial or may prevent sufficient compliance
- Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- Known or persistent abuse of medication, drugs or alcohol within 365 days prior to screening
Exclusion criteria regarding special restrictions for females:
- Current or planned pregnancy or nursing women
- Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized, sexually abstinent.
Indication specific exclusion criteria:
Patients with previous upper gastrointestinal tract surgery (e. g. Whipple procedure, panceas-sparing duodenectomy)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in total number of complete examinations of the MDP in the study groups
- Secondary Outcome Measures
Name Time Method - Rate of patients with different score values (0-3) for the macroscopical judgement of histopathological results of the MDP <br>- polyp detection in terms of size and number in the duodenum<br>- the time needed to locate the MDP<br>- differences in Spigelman classification <br>- occurence of (serious<br>