Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial
Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial (PRADA Trial)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Age \> 18 years 2. Patients with compensated cirrhosis with a higher risk of decompensation based on AASLD 2023 Practice Guidance (Kaplan et al) - no ascites with endoscopic visualization of varices 3. Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy. 4. No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy 5. MELD \< 20 6. First de novo RTO procedure 7. Taking NSBB 8. Patent internal jugular or right common femoral vein 9. Willing to provide the hepatology service information for F/U 10. No known diagnosis of hypercoagulopathy 11. Patent portal vein or portal vein cavernous transformation Exclusion Criteria: 1. Age \<18 years 2. Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al) 3. Cardiac failure 4. Active variceal bleeding 5. History of gastroesophageal variceal bleeding 6. Previous TIPS, BRTO, CARTO or PARTO procedure 7. No right jugular or right common femoral venous access 8. No portal vein flow 9. Malignancy 10. Life expectancy of less than 6 months
About the study
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.
What is being tested
- Non-selective beta blockers (drug)
- Retrograde transvenous obliteration (procedure)
Sponsor: University of California, Los Angeles · Participants: 68 · Started: Oct 1, 2026
Contact the study team
- Edward W. Lee, MD, PhD · Phone: 310-267-8771
Official record on ClinicalTrials.gov — NCT07168395
Locations in the U.S.
| California | University of California, Los Angeles, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.