Decompression Intervention of Variceal Rebleeding Trial (DIVERT)
2 other identifiers
interventional
140
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 1996
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1996
CompletedFirst Submitted
Initial submission to the registry
August 8, 2000
CompletedFirst Posted
Study publicly available on registry
August 9, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedJanuary 13, 2010
January 1, 2010
August 8, 2000
January 12, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior shunt procedure
- Portal vein thrombosis
- Polycystic liver disease
- Intractable ascites
- Prior organ transplant
- Any medical intractable disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Miami School of Medicine
Miami, Florida, 31336, United States
Emory University
Atlanta, Georgia, 30322, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
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. doi: 10.1016/j.jhep.2007.08.014. Epub 2007 Oct 23.
PMID: 18045724DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 8, 2000
First Posted
August 9, 2000
Study Start
December 1, 1996
Study Completion
December 1, 2003
Last Updated
January 13, 2010
Record last verified: 2010-01