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A Prospective Evaluation of Computerized Tomographic(CT) Scanning as a Screening Modality for Esophageal Varices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587197
First Posted: January 7, 2008
Last Update Posted: November 10, 2009
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.
Information provided by:
Mayo Clinic
  Purpose
Patients with cirrhosis require endoscopic screening for large esophageal varices. The aims of this study were to determine the cost -effectiveness and patient preferences of a strategy employing abdominal computerized tomography (CT) as the initial screening test for identifying large esophageal varices. In a prospective evaluation,102 patients underwent both CT and endoscopic screening for gastroesophageal varices. Two radiologists read each CT independently; standard upper gastrointestinal endoscopy was the reference standard. Agreement between radiologists, and between endoscopists regarding size of varices was determined using kappa statistic. Cost-effectiveness analysis was performed to determine the optimal screening strategy for varices. Patient preference was assessed by questionnaire. CT was found to have an approximately 90% sensitivity in the identification of esophageal varices determined to be large on endoscopy, but only about 50% specificity. The sensitivity of CT in detecting gastric varices was 87%. In addition, a significant additional number of gastric varices, peri-esophageal varices, and extraluminal pathology were identified by CT but not identified by endoscopy. Patients overwhelmingly preferred CT over endoscopy . Agreement between radiologists was good regarding the size of varices (Kappa = 0.56), and exceeded agreement between endoscopists (Kappa = 0.36). Use of CT as the initial screening modality for the detection of varices was significantly more cost-effective compared to endoscopy irrespective of the prevalence of large varices. In conclusion, abdominal CT as the initial screening test for varices could be cost-effective. CT also permits evaluation of extra-luminal pathology that impacts management.

Condition
Esophageal Varices Portal Hypertension Gastric Varices

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Accuracy of Contrast Abdominal CT for the Detection of High-Grade Esophageal and Gastric Varices in Patients With Cirrhosis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 134
Study Start Date: January 2003
Study Completion Date: December 2007
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with cirrhosis
Criteria

Inclusion Criteria:

  • Cirrhosis

Exclusion Criteria:

  • Recent bleed
  • Previous TIPS
  • Inability to provide consent
  • Renal insufficiency
  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): NCT00587197


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Patrick S Kamath, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Patrick S. Kamath, mayo Clinic
ClinicalTrials.gov Identifier: NCT00587197     History of Changes
Other Study ID Numbers: 1319-02
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Mayo Clinic:
esophageal varices
portal hypertension
gastric varices
cost effectiveness

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


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