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

Not Applicable

Completed

• Conditions: Cirrhosis; Gastric Bleeding
• Interventions: Procedure: Portacaval shunt; Procedure: Sclerotherapy

• Registration Number: NCT00820781
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1977-08
• Primary Completion: 1977-12
• Study Completion: 2003-04
• Status Verified: 2008-12
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Last Update Submitted: 2009-01-09
• Study First Posted: 2009-01-12
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Portacaval shunt	Portacaval shunt	Undergo portacaval shunt surgery
Sclerotherapy	Sclerotherapy	Undergo endoscopic sclerotherapy

Primary Outcome Measures

Name	Time	Method
Survival	10 years

Secondary Outcome Measures

Name	Time	Method
Control of bleeding and quality of life	10 years

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States