Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla
Not Applicable
Completed
- Conditions
- Visualisation and Evaluation of Ampulla of Vater
- Registration Number
- NCT02877797
- Lead Sponsor
- Technical University of Munich
- Brief Summary
Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Inclusion Criteria
- Indication of Esophagogastroduodenoscopy independent from the study
- Written informed
- Age ≥ 18 years
Exclusion Criteria
- Absence of written informed consent
- Contraindication or absence of informed consent regarding sedation with Propofol
- Postoperativ changes of the upper GI-tract
- Intention of endoscopic intervention
- Suspicion of upper GI-bleeding
- Suspicion of stenosis of the esophagus
- Stent in the papilla duodeni major
- ASA (American Society of Anesthesiologists) classification ≥ 3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Rate of complete visualisation of papilla duodeni major 120 seconds visualisation: none, incomplete, complete
- Secondary Outcome Measures
Name Time Method time of investigation up to 10 minutes Duration of Esophagogastroduodenoscopy
Diagnostic yield in the upper GI-tract up to 10 minutes All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)
complication rate up to one week Any complications related to the examination within one week would be reported.
Trial Locations
- Locations (1)
Klinikum rechts der Isar der Technischen Universität München
🇩🇪Munich, Bavaria, Germany
Klinikum rechts der Isar der Technischen Universität München🇩🇪Munich, Bavaria, Germany