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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014