Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

This study has been completed.

First Received on August 8, 2000. Last Updated on January 12, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00006161

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 III

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Esophagus Disorders High Blood Pressure Varicose Veins

U.S. FDA Resources

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

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

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
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):

Boyer TD, Henderson JM, Heerey AM, Arrigain S, Konig V, Connor J, Abu-Elmagd K, Galloway J, Rikkers LF, Jeffers L; DIVERT Study Group. Cost of preventing variceal rebleeding with transjugular intrahepatic portal systemic shunt and distal splenorenal shunt. J Hepatol. 2008 Mar;48(3):407-14. Epub 2007 Oct 23.

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
Esophageal Diseases
Liver Cirrhosis
Fibrosis
Varicose Veins
Gastrointestinal Diseases

Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012