Back to resultsThe Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Primary Purpose
Liver Cirrhoses, Portal Hypertension, Gastric Varix
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Propranolol
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhoses
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of liver cirrhosis
- Clinical diagnosis of isolated gastric varices
- The presenec of spontaneous portosystemic shunt
Exclusion Criteria:
- Contradictions to Propranolol
- Balloon occluded retrograde transvenous obliteration was failed
Sites / Locations
- West china HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Propranolol group
control group
Arm Description
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Outcomes
Primary Outcome Measures
Worsening of esophageal varices rate
Analysis
Secondary Outcome Measures
Variceal rebleeding rate
Analysis
Mortality rate
Analysis
Worsening of ascites rate
Analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171805
Brief Title
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Official Title
Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses, Portal Hypertension, Gastric Varix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propranolol group
Arm Type
Experimental
Arm Description
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
Primary Outcome Measure Information:
Title
Worsening of esophageal varices rate
Description
Analysis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Variceal rebleeding rate
Description
Analysis
Time Frame
3 years
Title
Mortality rate
Description
Analysis
Time Frame
3 years
Title
Worsening of ascites rate
Description
Analysis
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of liver cirrhosis
Clinical diagnosis of isolated gastric varices
The presenec of spontaneous portosystemic shunt
Exclusion Criteria:
Contradictions to Propranolol
Balloon occluded retrograde transvenous obliteration was failed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuefeng luo
Phone
02885422311
Email
luo_xuefeng@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xuefeng luo
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West china Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuefeng luo
Phone
02885422311
Email
luo_xuefeng@yeah.net
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
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