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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006161
First Posted: August 9, 2000
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
August 8, 2000
August 9, 2000
January 13, 2010
December 1996
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Complete list of historical versions of study NCT00006161 on ClinicalTrials.gov Archive Site
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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Esophageal and Gastric Varices
  • Liver Cirrhosis
  • Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
  • Procedure: Distal Splenorenal Shunt
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2003
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00006161
DIVERT (completed)
DK50680-02
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

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