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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587197
First received: December 21, 2007
Last updated: November 9, 2009
Last verified: November 2009
  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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587197

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

Additional Information:
No publications provided

Responsible Party: Patrick S. Kamath, mayo Clinic
ClinicalTrials.gov Identifier: NCT00587197     History of Changes
Other Study ID Numbers: 1319-02
Study First Received: December 21, 2007
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014