Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial (NCT07168395) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial
68 participantsStarted 2025-11
Plain-language 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 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 can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Age \<18 years
✕. Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)