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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)



Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

For Condition: Esophageal and Gastric Varices,Liver Cirrhosis
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis. This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Variceal bleeding secondary to cirrhosis and portal hypertension - Child's Class A or B cirrhosis of any etiology - Patients who have failed endoscopic therapy (sclerotherapy or banding) of varices; or patients who are not candidates for endoscopic therapy Exclusion Criteria: - Prior shunt procedure - Portal vein thrombosis - Polycystic liver disease - Intractable ascites - Prior organ transplant - Any medical intractable disease
Total Enrollment: 140

Location and Contact Information:

Overall Study Official:
J.Henderson,  Principal Investigator,  Cleveland Clinic Foundation Hospital

Emory University
Atlanta,  Georgia,  30322
United States
 

University of Wisconsin
Madison,  Wisconsin,  53792
United States
 

University of Pittsburgh Medical Center
Pittsburgh,  Pennsylvania,  15213
United States
 

Cleveland Clinic Foundation
Cleveland,  Ohio,  44195
United States
 

University of Miami School of Medicine
Miami,  Florida,  31336
United States
 


Additional Information:
Study ID Numbers:
  DIVERT;  DK50680-02
Study Start Date: December 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006161

Other Liver Cirrhosis Studies:
1. Prevention of Esophageal Varices by Beta-Adrenergic Blockers

2. A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients with Cirrhosis

3. Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

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