familial adenomatous polyposis
Conditions
Interventions
Group 1: In treatment arm A, an EGD is first performed with a standard endoscope. The patient is then examined directly up to the MDP with photo documentation and macroscopic evaluation of size and ap
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonnvertreten durch die Medizinische Fakultät der Universität Bonnvertreten durch den Dekan der Medizinischen FakultätVenusberg-Campus 153127 Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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)
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in total number of complete examinations of the MDP in the study groups | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of patients with different score values (0-3) for the macroscopical judgement of histopathological results of the MDP - polyp detection in terms of size and number in the duodenum - the time needed to locate the MDP - differences in Spigelman classification - occurence of (serious | — |
Countries
Germany
Contacts
Public ContactRobert Hüneburg
Nationales Zentrum für erbliche Tumorsyndrome (NZET)Medizinische Klinik und Poliklinik IUniversitätsklinikum Bonn
Outcome results
None listed