Decompression Intervention of Variceal Rebleeding Trial (DIVERT) - Tabular View

Tracking Information

First Received Date ^ICMJE

August 8, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

December 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

Official Title ^ICMJE

Decompression Intervention of Variceal Rebleeding Trial

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Esophageal and Gastric Varices
Liver Cirrhosis

Intervention ^ICMJE

Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Procedure: Distal Splenorenal Shunt

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00006161

Responsible Party

Study ID Numbers ^ICMJE

DIVERT, DK50680-02

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

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

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP