San Diego Bleeding Esophageal Varices Study

Not Applicable

Completed

• Conditions: Survival and Control of Bleeding
• Interventions: Procedure: Emergency and long-term endoscopic sclerotherapy; Procedure: Emergency portacaval shunt

• Registration Number: NCT00690027
• Lead Sponsor: 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.

Detailed Description

See attached Synopsis - APPENDIX 1

Study Timeline

• Study Start: 1988-04
• Primary Completion: 1996-08
• Study Completion: 2005-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Last Update Submitted: 2008-06-03
• Study First Posted: 2008-06-04
• Last Update Posted: 2008-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Emergency and long-term endoscopic sclerotherapy	Emergency endoscopic sclerotherapy
A	Emergency portacaval shunt	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.

Primary Outcome Measures

Name	Time	Method
Survival	10 years

Secondary Outcome Measures

Name	Time	Method
Control of bleeding and quality of life	10 years

Trial Locations

Locations (1)

200 West Arbor Drive; 🇺🇸 San Diego, California, United States