Decompression Intervention of Variceal Rebleeding Trial (DIVERT) - Full Text View

Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

Cirrhosis Esophagus Disorders Varicose Veins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study

Official Title:	Decompression Intervention of Variceal Rebleeding Trial

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

Publications indexed to this study:

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.

Study ID Numbers:	DIVERT, DK50680-02
First Received:	August 8, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006161
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

Study placed in the following topic categories:

Liver Diseases

Esophageal disorder

Fibrosis

Gastrointestinal Diseases

Vascular Diseases

Liver Cirrhosis

Hypertension, Portal

Hemorrhage

Portal hypertension

Digestive System Diseases

Varicose Veins

Esophageal and Gastric Varices

Esophageal Diseases

Hypertension

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008