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Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.
BACKGROUND: In patients with cirrhosis, bleeding gastric varices (BGV) are associated with a high mortality rate, but have received much less investigation than bleeding esophageal varices. Various therapeutic measures have been used to treat BGV, including endoscopic, radiographic, and surgical procedures, but there have been few prospective evaluations of therapy involving sizable groups of patients that have received acceptable follow-up. Management of this serious disorder has been uncertain and often unsuccessful. Herein is a prospective randomized controlled trial in unselected cirrhotic patients with BGV that compared the effectiveness of endoscopic therapy (ET) and portacaval shunt (PCS) during follow-up for more than 5 years or until death. STUDY DESIGN: 518 unselected patients with cirrhosis and BGV were randomized to ET or PCS performed as an emergency in 220 and electively in 298. All patients received the same diagnostic workup, initial therapy, post-treatment therapy, and rigorous follow-up. One-, 5-, 10-, and 15-year follow-up rates were 100%, 97%, 97%, and 92%, respectively. ET consisted of repetitive sessions of intravariceal injection sclerotherapy and/or variceal band ligation aimed at variceal obliteration. PCS consisted of a direct anastomosis, side to side in 95%. ET and PCS were compared specifically with regard to control of bleeding, survival rate, and quality of life.
Age
All ages
Sex
ALL
Healthy Volunteers
No
UCSD Medical Center
San Diego, California, United States
Start Date
August 1, 1977
Primary Completion Date
December 1, 1977
Completion Date
April 1, 2003
Last Updated
January 12, 2009
518
ACTUAL participants
Portacaval shunt
PROCEDURE
Sclerotherapy
PROCEDURE
Lead Sponsor
University of California, San Diego
NCT05597488
NCT06932783
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06306963