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

NCT00587197 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2009-11-10

No results posted yet for this study

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.

Conditions

  • Esophageal Varices
  • Portal Hypertension
  • Gastric Varices

Sponsors & Collaborators

Principal Investigators

  • Patrick S Kamath, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-10-31
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587197 on ClinicalTrials.gov