UCSD Medical Center
San Diego, California, 92103-8999, United States
NCT Number: NCT00820781
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
San Diego, California, 92103-8999, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subject taken to the operating room and undergoes portacaval shunt surgery
Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy
Time frame: 10 years
Time frame: 10 years
University of California, San Diego
Other
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
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.
Published trials that share one or more normalized conditions with this study.
NCT07417163
Cirrhosis, Dyssomnias
Boston, Massachusetts, United States
View Trial DetailsNCT07703540
Cirrhosis, Digestive System Diseases
Münster, North Rhine-Westphalia, Germany
View Trial DetailsNCT06062108
Acute Pain, Chronic Pain
Draguignan, Var, France
View Trial DetailsNCT03849235
Cirrhosis, Digestive System Diseases
Hvidovre, Capital Region Denmark, Denmark
View Trial Details