Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Not Applicable

Completed

• Conditions: Duodenal Papilla, Major
• Interventions: Procedure: cap assisted forward-viewing endoscope

• Registration Number: NCT02883608
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Primary Completion: 2016-10
• Study Completion: 2017-01-22
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Initial cap assisted endoscopy	cap assisted forward-viewing endoscope	undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope
Initial standard endoscopy	cap assisted forward-viewing endoscope	undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration needed to localize the papilla	within 5 minutes after intubation of the esophagus

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Bayern, Germany