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

May 22, 2017 updated by: Mohamed Abdelhafez, Technical University of Munich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81675
        • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial cap assisted endoscopy
undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope
Procedure: cap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope
Active Comparator: Initial standard endoscopy
undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope
Procedure: cap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 5 minutes after intubation of the esophagus

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration needed to localize the papilla
Time Frame: within 5 minutes after intubation of the esophagus
within 5 minutes after intubation of the esophagus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

January 22, 2017

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 216/16 s

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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