Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices
Primary Purpose
Gastric Bleeding, Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portacaval shunt
Sclerotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Bleeding focused on measuring bleeding gastric varices, cirrhosis of the liver, portacaval shunt, endoscopic variceal sclerotherapy, endoscopic variceal ligation, Bleeding gastric varices due to cirrhosis of the liver
Eligibility 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
Sites / Locations
- UCSD Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Portacaval shunt
Sclerotherapy
Arm Description
Undergo portacaval shunt surgery
Undergo endoscopic sclerotherapy
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Control of bleeding and quality of life
Full Information
NCT ID
NCT00820781
First Posted
January 8, 2009
Last Updated
January 9, 2009
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00820781
Brief Title
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices
Official Title
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 1977 (undefined)
Primary Completion Date
December 1977 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Bleeding, Cirrhosis
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
518 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Portacaval shunt
Arm Type
Active Comparator
Arm Description
Undergo portacaval shunt surgery
Arm Title
Sclerotherapy
Arm Type
Active Comparator
Arm Description
Undergo endoscopic sclerotherapy
Intervention Type
Procedure
Intervention Name(s)
Portacaval shunt
Intervention Description
Subject taken to the operating room and undergoes portacaval shunt surgery
Intervention Type
Procedure
Intervention Name(s)
Sclerotherapy
Intervention Description
Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy
Primary Outcome Measure Information:
Title
Survival
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Control of bleeding and quality of life
Time Frame
10 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall J Orloff, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8999
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25957003
Citation
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.
Results Reference
derived
Learn more about this trial
Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding Gastric Varices
We'll reach out to this number within 24 hrs