Visualisation and Evaluation of Ampulla of Vater
Conditions
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.
Interventions
DEVICECap
cap assisted esophagogastroduodenoscopy
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete visualisation of papilla duodeni major | 120 seconds | visualisation: none, incomplete, complete |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| time of investigation | up to 10 minutes | Duration of Esophagogastroduodenoscopy |
| complication rate | up to one week | Any complications related to the examination within one week would be reported. |
Countries
Germany
Outcome results
None listed