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

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ClinicalTrials.gov Identifier: NCT00820781
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Bleeding Cirrhosis Procedure: Portacaval shunt Procedure: Sclerotherapy Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
Study Start Date : August 1977
Actual Primary Completion Date : December 1977
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
Active Comparator: Portacaval shunt
Undergo portacaval shunt surgery
Procedure: Portacaval shunt
Subject taken to the operating room and undergoes portacaval shunt surgery

Active Comparator: Sclerotherapy
Undergo endoscopic sclerotherapy
Procedure: Sclerotherapy
Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy




Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Control of bleeding and quality of life [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820781


Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103-8999
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Marshall J Orloff, M.D. University of California, San Diego

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marshall J. Orloff, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT00820781     History of Changes
Other Study ID Numbers: ESTVPCSBGV
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: December 2008

Keywords provided by University of California, San Diego:
bleeding gastric varices
cirrhosis of the liver
portacaval shunt
endoscopic variceal sclerotherapy
endoscopic variceal ligation
Bleeding gastric varices due to cirrhosis of the liver

Additional relevant MeSH terms:
Hemorrhage
Fibrosis
Liver Cirrhosis
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal