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

Technical University of Munich

Status: Completed

Conditions: Duodenal Papilla, Major

Treatments: Procedure: cap assisted forward-viewing endoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02883608

216/16 s

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Initial cap assisted endoscopy

Experimental group

Description:

undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope

Treatment:

Procedure: cap assisted forward-viewing endoscope

Initial standard endoscopy

Active Comparator group

Description:

undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope

Treatment:

Procedure: cap assisted forward-viewing endoscope