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

NCT ID: NCT00475592

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-05-31

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.

Conditions

Esophageal and Gastric Varices

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Capsule Endoscopy

Group Type: EXPERIMENTAL

Esophageal Capsule Endoscopy

Intervention Type: DEVICE

Upper Gastrointestinal Endoscopy

Group Type: ACTIVE_COMPARATOR

Upper Gastrointestinal Endoscopy

Intervention Type: DEVICE

Interventions

Esophageal Capsule Endoscopy

Intervention Type: DEVICE

Upper Gastrointestinal Endoscopy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul J Thuluvath, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

VaricealGrading_EsoCapsule

Identifier Type: -

Identifier Source: org_study_id