San Diego Bleeding Esophageal Varices Study

University of California San Diego

Status: Completed

Conditions: Survival and Control of Bleeding

Treatments: Procedure: Emergency and long-term endoscopic sclerotherapy; Procedure: Emergency portacaval shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT00690027

ESTVEPCS

Details and patient eligibility

About

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.

Full description

See attached Synopsis - APPENDIX 1

Enrollment: 211 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 2 patient groups

A

Active Comparator group

Description:

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.

Treatment:

Procedure: Emergency portacaval shunt

B

Active Comparator group

Description:

Emergency endoscopic sclerotherapy

Treatment:

Procedure: Emergency and long-term endoscopic sclerotherapy