Retrograde Transvenous Obliteration for Gastric Varices
(PRADA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
A number of treatment modalities are currently in use for gastric variceal bleeding (GVB). Balloon-occluded, plug-assisted, and coil-assisted retrograde transvenous obliteration (RTO) procedures are described in the literature as treatments for GVB after a bleeding episode occurs. Preliminary data suggests that prophylactic treatment of gastric varices may improve patient outcomes compared to conservative management. This study aims to compare pre-emptive treatment of gastric varices with current recommended medical management in a randomized prospective study design. Eligible patients will be randomized to receive RTO or to continue conservative management. Patients will be followed for up to 2 years for comparison of clinical outcomes, including episodes of gastric variceal bleeding, overall survival and transplant-free survival, complications, and secondary interventions.
Who Is on the Research Team?
Edward W. Lee, MD, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for adults over 18 with compensated liver cirrhosis and gastric varices found on imaging, who are already taking non-selective beta blockers. Participants must have healthy major veins, no blood clotting disorders or cancer, and be eligible for their first RTO procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Retrograde Transvenous Obliteration
Trial Overview
The study compares two approaches: early (pre-emptive) treatment of gastric varices using a procedure called retrograde transvenous obliteration (RTO), versus standard medical management with non-selective beta blockers. Patients are randomly assigned to one group and followed for up to 2 years.
How Is the Trial Designed?
2
Treatment groups
Active Control
Non-selective beta blockers prescribed according to standard of care treatment guidelines. These may include propranolol, nadolol, and timolol.
Pre-emptive treatment with retrograde transvenous obliteration
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
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