Skip to main content
OpenTrials
Completed

NCT Number: NCT02883608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Duodenal Papilla, Major

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cap assisted forward-viewing endoscope

Procedure

a cap fitted to the to top of the forward-viewing endoscope

Primary outcomes

  1. Rate of complete visualisation of papilla duodeni major

    Time frame: 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 outcomes

  1. Duration needed to localize the papilla

    Time frame: within 5 minutes after intubation of the esophagus

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: KappaII

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.