The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02883621

Acronym

Kappa-III

Enrollment

1000

Registered

2016-08-30

Start date

2016-09-30

Completion date

2017-05-22

Last updated

2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Diagnosis in Esophagus

Keywords

upper endoscopy, cap assisted endoscopy, esophagus

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.

Interventions

PROCEDUREcap 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.

PROCEDUREstandard upper endoscopy

standard examination without using a cap

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026