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

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ClinicalTrials.gov Identifier: NCT00587197
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : November 10, 2009
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease
Esophageal Varices Portal Hypertension Gastric Varices

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 134 participants
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
Study Start Date : January 2003
Primary Completion Date : October 2005
Study Completion Date : December 2007

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

Inclusion Criteria:

  • Cirrhosis

Exclusion Criteria:

  • Recent bleed
  • Previous TIPS
  • Inability to provide consent
  • Renal insufficiency

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
Principal Investigator: Patrick S Kamath, MD Mayo Clinic

Additional Information:
Responsible Party: Patrick S. Kamath, mayo Clinic
ClinicalTrials.gov Identifier: NCT00587197     History of Changes
Other Study ID Numbers: 1319-02
First Posted: January 7, 2008    Key Record Dates
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, Portal
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases