A Prospective Evaluation of Computerized Tomographic(CT) Scanning as a Screening Modality for Esophageal Varices
The Accuracy of Contrast Abdominal CT for the Detection of High-Grade Esophageal and Gastric Varices in Patients With Cirrhosis
1 other identifier
observational
134
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2003
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedNovember 10, 2009
November 1, 2009
2.8 years
December 21, 2007
November 9, 2009
Conditions
Keywords
Eligibility Criteria
patients with cirrhosis
You may qualify if:
- Cirrhosis
You may not qualify if:
- Recent bleed
- Previous TIPS
- Inability to provide consent
- Renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick S Kamath, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
January 1, 2003
Primary Completion
October 1, 2005
Study Completion
December 1, 2007
Last Updated
November 10, 2009
Record last verified: 2009-11