San Diego Bleeding Esophageal Varices Study

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT00690027
• Collaborator: (none)
• Enrollment: 211
• Location: 1
• Arms: 2
• Duration (Months): 212
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

Detailed Description

See attached Synopsis - APPENDIX 1

Study Design

• Study Type: Interventional
• 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: Apr 1, 1988
• Actual Primary Completion Date: Aug 1, 1996
• Actual Study Completion Date: Dec 1, 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Survival [10 years]

Secondary Outcome Measures

1. Control of bleeding and quality of life [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00690027
• Other Study ID Numbers: ESTVEPCS
• First Posted: Jun 4, 2008
• Last Update Posted: Jun 4, 2008
• Last Verified: Jun 1, 2008

• Additional relevant MeSH terms: Esophageal and Gastric Varices; Hemorrhage

Study Results

No Results Posted as of Jun 4, 2008