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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Gastric Bleeding
• Intervention / Treatment: Procedure: Portacaval shunt; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103-8999
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Control of bleeding and quality of life	10 years

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Marshall J Orloff, M.D., University of California, San Diego

Publications and helpful links

General Publications

• Orloff MJ, Hye RJ, Wheeler HO, Isenberg JI, Haynes KS, Vaida F, Girard B, Orloff KJ. Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis. Surgery. 2015 Jun;157(6):1028-45. doi: 10.1016/j.surg.2014.12.003.

Study record dates

Study Major Dates

• Study Start: August 1, 1977
• Primary Completion (ACTUAL): December 1, 1977
• Study Completion (ACTUAL): April 1, 2003

Study Registration Dates

• First Submitted: January 8, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (ESTIMATE): January 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2009
• Last Update Submitted That Met QC Criteria: January 9, 2009
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: 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: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Fibrosis; Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices
• Other Study ID Numbers: ESTVPCSBGV