MedTrace Logo

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

NCT07168395 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Gastric Varices

Interventions

DRUG

Non-selective beta blockers

Non-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.

PROCEDURE

Retrograde transvenous obliteration

Pre-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.

Sponsors & Collaborators

Principal Investigators

  • Edward W. Lee, MD, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-11-30
Completion
2028-11-30

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168395 on ClinicalTrials.gov