Duodenal Papilla, Major
Conditions
Keywords
Papilla, major duodenal papilla, ampulla of vater
Brief summary
Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side\*viewing duodenoscope for complete examination of MDP.
Interventions
PROCEDUREcap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope
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
Yes
Inclusion criteria
* indication for elective upper endoscopy * age over 18 years * ability to provide informed consent
Exclusion criteria
* surgically altered upper gastrointestinal tract * known or suspected upper gastrointestinal strictures * upper gastrointestinal bleeding * biliary stent * planned endoscopic intervention * American Society of Anesthesiologists class III or higher * contraindication for or refusal of sedation with Propofol * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete visualisation of papilla duodeni major | within 5 minutes after intubation of the esophagus | complete visualization is defined by visualization of both proximal and distal ends together with the orifice of the papilla |
Secondary
| Measure | Time frame |
|---|---|
| Duration needed to localize the papilla | within 5 minutes after intubation of the esophagus |
Countries
Germany
Outcome results
None listed