The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Not Applicable

Completed

• Conditions: Endoscopic Diagnosis in Esophagus
• Interventions: Procedure: standard upper endoscopy; Procedure: cap assisted upper endoscopy

• Registration Number: NCT02883621
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Study Start: 2016-09
• Primary Completion: 2017-04
• Status Verified: 2017-05
• Study Completion: 2017-05-22
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	standard upper endoscopy	subjects receive standard upper endoscopy
Group B	cap assisted upper endoscopy	subjects receive cap assisted upper endoscopy

Primary Outcome Measures

Name	Time	Method
Diagnostic yield in esophagus	15 Minutes	All endoscopic abnormalities in esophagus which are detected during the examination in both groups will be documented, analyzed and compared

Secondary Outcome Measures

Name	Time	Method
Overall diagnostic yield in upper gastrointestinal tract.	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

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Bayern, Germany