Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Age <18 years

Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)

Cardiac failure

Active variceal bleeding

Trial design

Treatments tested in this trial

  • Non-selective beta blockers
  • Retrograde transvenous obliteration

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

This trial has no locations