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.
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
Age <18 years
Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
Cardiac failure
Active variceal bleeding
Parallel
Non-selective beta blockers
DrugNon-selective beta blockers are used in patients who have not had a previous variceal bleed to prevent bleeding by reducing blood pressure in the liver. These drugs also work by blocking beta receptors that reduce cardiac output and by causing vessel constriction in the abdominal organs, which lowers blood flow to the liver and the existing varices.
Retrograde transvenous obliteration
Procedure/SurgeryPre-emptive retrograde transvenous obliteration will be performed in patients randomized to this arm to evaluate the effectiveness in decreasing gastric variceal bleeding. Either CARTO or PARTO (coil or plug-assisted retrograde transvenous obliteration) will be performed using EMBOLIZATION COILS or VASCULAR PLUGS of different sizes based on the size of the shunt. Additionally, Gelfoam (collagen sponges) slurry will be injected into the shunt and varices to completely obliterate them.
Episodes of variceal bleeding
To monitor and assess the effectiveness of decreasing gastric variceal bleeding episodes between those receiving pre-emptive retrograde transvenous obliteration versus conservative management with non-selective beta blockers.
Complications
To compare complications related to retrograde transvenous obliteration versus conservative management with non-selective beta blockers, including worsening of gastric varices, other bleeding, ascites, or hepatic encephalopathy
Transplant-free survival
To compare the short term (1 month), mid-term (3 months and 6 months), and long-term (every 3 months up to two years) outcomes of episodes of gastric variceal bleeding, overall survival and transplant-free survival, complications, and secondary interventions.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
