San Diego Bleeding Esophageal Varices Study

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00690027
First received: June 3, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention
Survival and Control of Bleeding
Procedure: Emergency portacaval shunt
Procedure: Emergency and long-term endoscopic sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: San Diego Bleeding Esophageal Varices Study

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Survival [ Time Frame: 10 years ]

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

Enrollment: 211
Study Start Date: April 1988
Study Completion Date: December 2005
Primary Completion Date: August 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

See attached Synopsis - APPENDIX 1

  Eligibility

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of California, San Diego

Additional 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
Study First Received: June 3, 2008
Last Updated: June 3, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014