Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Decompression Intervention of Variceal Rebleeding Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 31336
        • University of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: J. Michael Henderson, M.D., The Cleveland Clinic
  • Principal Investigator: Thomas D. Boyer, M.D., Emory University
  • Principal Investigator: Lennox Jeffers, M.D., University of Miami
  • Principal Investigator: Enrique Molina, M.D., University of Miami
  • Principal Investigator: Layton F. Rikkers, M.D., University of Wisconsin, Madison
  • Principal Investigator: Kareem Abu-Elmagd, M.D., University of Pittsburgh Medical Center
  • Principal Investigator: Amrik Shah, Sc.D., Cleveland Clinic Foundation - Data Coordinating Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

August 8, 2000

First Submitted That Met QC Criteria

August 8, 2000

First Posted (Estimate)

August 9, 2000

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIVERT (completed)
  • DK50680-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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