Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006161
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Esophageal and Gastric Varices
Liver Cirrhosis
Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Procedure: Distal Splenorenal Shunt
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Decompression Intervention of Variceal Rebleeding Trial

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 140
Study Start Date: December 1996
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006161

Locations
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 31336
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
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
Principal Investigator: Amrik Shah, Sc.D. Cleveland Clinic Foundation - Data Coordinating Center
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00006161     History of Changes
Obsolete Identifiers: NCT00004469
Other Study ID Numbers: DIVERT (completed), DK50680-02
Study First Received: August 8, 2000
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
TIPS
DSRS
Varices
Variceal bleeding
Splenorenal Shunt
Transjugular Intrahepatic Portosystemic Shunt
Cirrhosis
Portal hypertension
Liver disease

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Liver Cirrhosis
Fibrosis
Varicose Veins
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014