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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00475592
First received: May 16, 2007
Last updated: December 15, 2010
Last verified: May 2007
  Purpose

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


Condition Intervention
Esophageal and Gastric Varices
Device: Esophageal Capsule Endoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy. [ Time Frame: Two years ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Two years ]

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475592

Contacts
Contact: Paul J Thuluvath, MD 410-614-5389 pjthuluv@jhmi.edu
Contact: Karen L Krok, MD 410-955-4916 karen.krok@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Paul J Thuluvath, MD         
Sub-Investigator: Karen L Krok, MD         
Sponsors and Collaborators
Johns Hopkins University
Ethicon, Inc.
Investigators
Principal Investigator: Paul J Thuluvath, MD Johns Hopkins Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00475592     History of Changes
Other Study ID Numbers: VaricealGrading_EsoCapsule
Study First Received: May 16, 2007
Last Updated: December 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Esophageal Varices
Gastric Varices
Capsule Endoscopy
Portal Hypertension
Cirrhosis
Gastrointestinal Hemorrhage

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Varicose Veins
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014