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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

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:

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




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