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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

Primary Purpose

Esophageal and Gastric Varices, Liver Cirrhosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Distal Splenorenal Shunt

About this trial

This is an interventional treatment trial for Esophageal and Gastric Varices focused on measuring TIPS, DSRS, Varices, Variceal bleeding, Splenorenal Shunt, Transjugular Intrahepatic Portosystemic Shunt, Cirrhosis, Portal hypertension, Liver disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Miami School of Medicine
Emory University
Cleveland Clinic Foundation
University of Pittsburgh Medical Center
University of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006161

First Posted

August 8, 2000

Last Updated

January 12, 2010

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00006161

Brief Title

Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

Official Title

Decompression Intervention of Variceal Rebleeding Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

December 1996 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal and Gastric Varices, Liver Cirrhosis

Keywords

TIPS, DSRS, Varices, Variceal bleeding, Splenorenal Shunt, Transjugular Intrahepatic Portosystemic Shunt, Cirrhosis, Portal hypertension, Liver disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

140 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type

Procedure

Intervention Name(s)

Distal Splenorenal Shunt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: