The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Endoscopic Diagnosis in Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group A

subjects receive standard upper endoscopy

Group Type ACTIVE_COMPARATOR

standard upper endoscopy

Intervention Type PROCEDURE

standard examination without using a cap

Group B

subjects receive cap assisted upper endoscopy

Group Type EXPERIMENTAL

cap assisted upper endoscopy

Intervention Type PROCEDURE

A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.

Interventions

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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.

Intervention Type PROCEDURE

standard upper endoscopy

standard examination without using a cap

Intervention Type PROCEDURE

Other Intervention Names

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cap fitted upper endoscopy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes