Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

Not Applicable

Withdrawn

• Conditions: Esophageal and Gastric Varices
• Interventions: Device: Esophageal Capsule Endoscopy; Device: Upper Gastrointestinal Endoscopy

• Registration Number: NCT00475592
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

Detailed Description

Up to 35% of patients with cirrhosis will develop esophageal varices, which carry with them a 1-year and 3-year bleeding rate of 33% and 41%, respectively. Screening for varices with a video endoscopy is limited by its cost, patient compliance, and the risks of sedating a patient with portal hypertension. Capsule endoscopy is a novel method that may reduce the costs and increase compliance for screening.

The investigators propose to screen 100 consecutive patients with advanced cirrhosis for esophageal varices. A capsule endoscopy and video endoscopy will be done on the same day. The varices seen on video endoscopy will be graded using a standard grading scale. Both capsule and video endoscopy images will be assessed in a blinded fashion by 4 independent investigators. Finally, the video endoscopic images will be compared to capsule endoscopy to develop a capsule endoscopy grading system that corresponds to video endoscopy.

The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. Secondary endpoints of the study include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance as assessed on a visual analogue scale; and a cost comparison (facility fees + professional fees) of the two screening methods.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-21
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
• Age greater than or equal to 18 years old
• Able to give consent

Exclusion Criteria

• Current implantable cardioverter-defibrillators or pacemaker in place
• Suspected intestinal obstruction
• Esophageal swallowing disorder
• Esophageal stenosis
• Age less than 18 years old
• Pregnancy
• Known Zenker's diverticulum
• Patients with previous endoscopic or surgical esophageal treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsule Endoscopy	Esophageal Capsule Endoscopy	-
Upper Gastrointestinal Endoscopy	Upper Gastrointestinal Endoscopy	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.	Two years

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.	Two years

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States