Status:
NOT_YET_RECRUITING
Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial
Lead Sponsor:
University of California, Los Angeles
Conditions:
Gastric Varices
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 d...
Detailed Description
Gastroesophageal varices occur in approximately 50% of patients with liver cirrhosis. Specifically, gastric varices (GV) are responsible for roughly 10-30% of all variceal hemorrhage which is less tha...
Eligibility Criteria
Inclusion
- Age \> 18 years
- 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
- Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.
- No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy
- MELD \< 20
- First de novo RTO procedure
- Taking NSBB
- Patent internal jugular or right common femoral vein
- Willing to provide the hepatology service information for F/U
- No known diagnosis of hypercoagulopathy
- Patent portal vein or portal vein cavernous transformation
Exclusion
- Age \<18 years
- Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
- Cardiac failure
- Active variceal bleeding
- History of gastroesophageal variceal bleeding
- Previous TIPS, BRTO, CARTO or PARTO procedure
- No right jugular or right common femoral venous access
- No portal vein flow
- Malignancy
- Life expectancy of less than 6 months
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT07168395
Start Date
November 1 2025
End Date
November 1 2028
Last Update
September 11 2025
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