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San Diego Bleeding Esophageal Varices Study

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ClinicalTrials.gov Identifier: NCT00690027
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
University of California, San Diego

Brief Summary:

In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

  • Emergency portacaval shunt, and
  • Emergency and long-term endoscopic sclerotherapy.

Condition or disease Intervention/treatment Phase
Survival and Control of Bleeding Procedure: Emergency portacaval shunt Procedure: Emergency and long-term endoscopic sclerotherapy Not Applicable

Detailed Description:
See attached Synopsis - APPENDIX 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: San Diego Bleeding Esophageal Varices Study
Study Start Date : April 1988
Actual Primary Completion Date : August 1996
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A

Objective: See Brief Summary, page 2. Eligibility: Patients who require > 2 units blood transfusion for bleeding esophageal varices due to cirrhosis.

Randomization: By the blind card method to emergency portacaval shunt (EPCS) or emergency endoscopic sclerotherapy (EST) followed by long-term repetitive EST.

Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 8hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months, or rebleeding after varices were obliterated.

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
Active Comparator: B
Emergency endoscopic sclerotherapy
Procedure: Emergency and long-term endoscopic sclerotherapy



Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Control of bleeding and quality of life [ Time Frame: 10 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
  • Those who are shown to have the findings of cirrhosis and esophageal varices that:

    • Are seen to be actively bleeding;
    • Have an adherent clot;
    • Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
  • Require 2 or more units of blood transfusion, will be included in the study.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690027


Locations
United States, California
200 West Arbor Drive
San Diego, California, United States, 92103-8999
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Marshall J Orloff, M.D. UCSD Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marshall J. Orloff, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT00690027     History of Changes
Other Study ID Numbers: ESTVEPCS
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Hemorrhage
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases