Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla (Kappa-I)

August 19, 2016 updated by: Monther Bajbouj, Technical University of Munich

The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla

Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • 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 of Esophagogastroduodenoscopy independent from the study
  • Written informed
  • Age ≥ 18 years

Exclusion Criteria:

  • Absence of written informed consent
  • Contraindication or absence of informed consent regarding sedation with Propofol
  • Postoperativ changes of the upper GI-tract
  • Intention of endoscopic intervention
  • Suspicion of upper GI-bleeding
  • Suspicion of stenosis of the esophagus
  • Stent in the papilla duodeni major
  • ASA (American Society of Anesthesiologists) classification ≥ 3

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
No Intervention: standard Esophagogastroduodenoscopy
Experimental: cap assisted Esophagogastroduodenoscopy
Device: Cap
cap assisted esophagogastroduodenoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete visualisation of papilla duodeni major
Time Frame: 120 seconds
visualisation: none, incomplete, complete
120 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield in the upper GI-tract
Time Frame: up to 10 minutes
All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)
up to 10 minutes
time of investigation
Time Frame: up to 10 minutes
Duration of Esophagogastroduodenoscopy
up to 10 minutes
complication rate
Time Frame: up to one week
Any complications related to the examination within one week would be reported.
up to one week

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Stefan von Delius, Technical University of Munich

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

February 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 14/16S

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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