Clinical trial NCT00006161: Decompression Intervention of Variceal Rebleeding Trial (DIVERT)
Official title: Decompression Intervention of Variceal Rebleeding Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal and Gastric Varices
Liver Cirrhosis
Keywords: TIPS
DSRS
Varices
Variceal bleeding
Splenorenal Shunt
Transjugular Intrahepatic Portosystemic Shunt
Cirrhosis
Portal hypertension
Liver disease
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-08-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: J. Michael Henderson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Thomas D. Boyer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Lennox Jeffers, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Enrique Molina, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Layton F. Rikkers, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Kareem Abu-Elmagd, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Foundation - Data Coordinating Center
name: Amrik Shah, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.