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
  Purpose

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 Intervention
Gastric Bleeding
Cirrhosis
Procedure: Portacaval shunt
Procedure: Sclerotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of bleeding and quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 518
Study Start Date: August 1977
Study Completion Date: April 2003
Primary Completion Date: December 1977 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Marshall J. Orloff, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT00820781     History of Changes
Other Study ID Numbers: ESTVPCSBGV
Study First Received: January 8, 2009
Last Updated: January 9, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014