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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Primary Purpose

Bleeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency portacaval shunt
Emergency TIPS
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Survival and control of hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion Criteria:

  • None

Sites / Locations

  • UCSD Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months. Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians. Procedure: Emergency portacaval shunt.

Procedure: Emergency TIPS.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Control of bleeding and quality of life

Full Information

First Posted
August 13, 2008
Last Updated
August 13, 2008
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00734227
Brief Title
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Official Title
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
Survival and control of hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months. Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians. Procedure: Emergency portacaval shunt.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Procedure: Emergency TIPS.
Intervention Type
Procedure
Intervention Name(s)
Emergency portacaval shunt
Intervention Type
Other
Intervention Name(s)
Emergency TIPS
Primary Outcome Measure Information:
Title
Survival
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Control of bleeding and quality of life
Time Frame
10 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall J. Orloff, M.D.
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24402314
Citation
Orloff MJ. Fifty-three years' experience with randomized clinical trials of emergency portacaval shunt for bleeding esophageal varices in Cirrhosis: 1958-2011. JAMA Surg. 2014 Feb;149(2):155-69. doi: 10.1001/jamasurg.2013.4045. Erratum In: JAMA Surg. 2014 Jun;149(6):543.
Results Reference
derived
PubMed Identifier
23007280
Citation
Orloff MJ, Vaida F, Haynes KS, Hye RJ, Isenberg JI, Jinich-Brook H. Randomized controlled trial of emergency transjugular intrahepatic portosystemic shunt versus emergency portacaval shunt treatment of acute bleeding esophageal varices in cirrhosis. J Gastrointest Surg. 2012 Nov;16(11):2094-111. doi: 10.1007/s11605-012-2003-6. Epub 2012 Sep 25.
Results Reference
derived

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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

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