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

This study has been withdrawn prior to enrollment.
(study failed to recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00475592
First Posted: May 21, 2007
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Johns Hopkins University
  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 Device: Upper Gastrointestinal Endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 ]

Enrollment: 0
Actual Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capsule Endoscopy Device: Esophageal Capsule Endoscopy
Active Comparator: Upper Gastrointestinal Endoscopy Device: Upper Gastrointestinal Endoscopy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475592


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Ethicon, Inc.
Investigators
Principal Investigator: Paul J Thuluvath, MD Johns Hopkins University
  More Information

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00475592     History of Changes
Other Study ID Numbers: VaricealGrading_EsoCapsule
First Submitted: May 16, 2007
First Posted: May 21, 2007
Last Update Posted: July 24, 2017
Last Verified: July 2017

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
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases


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