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Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00820781
First received: January 8, 2009
Last updated: January 9, 2009
Last verified: December 2008

January 8, 2009
January 9, 2009
August 1977
December 1977   (final data collection date for primary outcome measure)
Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00820781 on ClinicalTrials.gov Archive Site
Control of bleeding and quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Gastric Bleeding
  • Cirrhosis
  • Procedure: Portacaval shunt
    Subject taken to the operating room and undergoes portacaval shunt surgery
  • Procedure: Sclerotherapy
    Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy
  • Active Comparator: Portacaval shunt
    Undergo portacaval shunt surgery
    Intervention: Procedure: Portacaval shunt
  • Active Comparator: Sclerotherapy
    Undergo endoscopic sclerotherapy
    Intervention: Procedure: Sclerotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
518
April 2003
December 1977   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers").

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00820781
ESTVPCSBGV
Yes
Marshall J. Orloff, M.D., University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Marshall J Orloff, M.D. University of California, San Diego
University of California, San Diego
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP