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

About

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 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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
Willing to provide the hepatology service information for F/U
No known diagnosis of hypercoagulopathy
Patent portal vein or portal vein cavernous transformation

Exclusion Criteria:

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