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Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

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ClinicalTrials.gov Identifier: NCT00006161
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE August 8, 2000
First Posted Date  ICMJE August 9, 2000
Last Update Posted Date January 13, 2010
Study Start Date  ICMJE December 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00006161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal and Gastric Varices
  • Liver Cirrhosis
Intervention  ICMJE
  • Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
  • Procedure: Distal Splenorenal Shunt
Study Arms Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
140
Original Enrollment  ICMJE Same as current
Study Completion Date December 2003
Primary Completion Date Not Provided
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006161
Other Study ID Numbers  ICMJE DIVERT (completed)
DK50680-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
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 Medical Center
Principal Investigator: Amrik Shah, Sc.D. Cleveland Clinic Foundation - Data Coordinating Center
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date January 2010

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