The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus (Kappa-III)

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

Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus

Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for upper endoscopy
  • age over 18 years
  • ability to provide informed consent

Exclusion Criteria:

  • known or suspected upper gastrointestinal strictures
  • upper gastrointestinal bleeding
  • previous upper endoscopy during the last three months
  • American Society of Anesthesiologists class III or higher

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
subjects receive standard upper endoscopy
Procedure: standard upper endoscopy
standard examination without using a cap
Experimental: Group B
subjects receive cap assisted upper endoscopy
Procedure: cap assisted upper endoscopy
A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.
Other Names:
  • cap fitted upper endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield in esophagus
Time Frame: 15 Minutes
All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared
15 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall diagnostic yield in upper gastrointestinal tract.
Time Frame: 15 Minutes
All other endoscopic abnormalities outside the esophagus (stomach and duodenum) which are detected during the examination in both groups will be documented, analyzed and compared
15 Minutes

Collaborators and Investigators

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

Sponsor

Technical University of Munich

Collaborators

Rotkreuzklinikum München gGmbH
Klinikum Freising
Klinikum Landshut-Achdorf
Städtisches Klinikum Neuperlach
Gemeinschaftspraxis Dr. Schatke & Dr. Ott
Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjak

Investigators

  • Principal Investigator: Mohamed Abdelhafez, MD, II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

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

September 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218/16 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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