The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Overview

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.

Full Title of Study: “Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2017

Interventions

• 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.
• Procedure: standard upper endoscopy
  • standard examination without using a cap

Arms, Groups and Cohorts

• Active Comparator: Group A
  • subjects receive standard upper endoscopy
• Experimental: Group B
  • subjects receive cap assisted upper endoscopy

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Technical University of Munich
• Collaborator
  • Klinikum Freising
• Provider of Information About this Clinical Study
  • Principal Investigator: Mohamed Abdelhafez, MD – Technical University of Munich
• Overall Official(s)
  • Mohamed Abdelhafez, MD, Principal Investigator, II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München