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OpenTrials
Completed

NCT Number: NCT00690027

San Diego Bleeding Esophageal Varices Study

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.

Completed

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Key information

Conditions

Survival and Control of Bleeding

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

200 West Arbor Drive

San Diego, California, 92103-8999, United States

About this study

See attached Synopsis - APPENDIX 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emergency portacaval shunt

Procedure

Emergency and long-term endoscopic sclerotherapy

Procedure

Primary outcomes

  1. Survival

    Time frame: 10 years

Secondary outcomes

  1. Control of bleeding and quality of life

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
1988
Primary completion
1996
Study completion
2005
First posted
Jun 4, 2008
Registry last updated
Jun 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.