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NCT00006161 Clinical Trial

Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

Liver Cirrhosis Clinical Trial

Official title:
Decompression Intervention of Variceal Rebleeding Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006161
Other study ID # DIVERT (completed)
Secondary ID DK50680-02
Status Completed
Phase Phase 3
First received August 8, 2000
Last updated January 12, 2010
Start date December 1996
Est. completion date December 2003

Study information
Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Other known NCT identifiers
  • NCT00004469

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Transjugular Intrahepatic Portosystemic Shunt (TIPS)

• Distal Splenorenal Shunt

Locations
Country Name City State
United States Emory University Atlanta Georgia
United States Cleveland Clinic Foundation Cleveland Ohio
United States University of Wisconsin Madison Wisconsin
United States University of Miami School of Medicine Miami Florida
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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