Decompression Intervention of Variceal Rebleeding Trial (DIVERT)

NCT ID: NCT00006161

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Esophageal and Gastric Varices Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type PROCEDURE

Distal Splenorenal Shunt

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Principal Investigators

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J. Michael Henderson, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Thomas D. Boyer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Lennox Jeffers, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Enrique Molina, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Layton F. Rikkers, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Kareem Abu-Elmagd, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Amrik Shah, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Foundation - Data Coordinating Center

Locations

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University of Miami School of Medicine

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18045724 (View on PubMed)

Other Identifiers

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DK50680-02

Identifier Type: -

Identifier Source: secondary_id

DIVERT (completed)

Identifier Type: -

Identifier Source: org_study_id

NCT00004469

Identifier Type: -

Identifier Source: nct_alias

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