Recruiting

RTO vs. Conservative Management

Sponsor:

UCLA

Code:

NCT07168395

Conditions

Gastric Varices

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-selective beta blockers

Retrograde transvenous obliteration

Study Details

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.

Conditions

Gastric Varices

Study ID

NCT07168395

Start date

Oct 1, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 18 years
2. 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
3. Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.
4. No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy
5. MELD < 20
6. First de novo RTO procedure
7. Taking NSBB
8. Patent internal jugular or right common femoral vein
9. Willing to provide the hepatology service information for F/U
10. No known diagnosis of hypercoagulopathy
11. Patent portal vein or portal vein cavernous transformation

Exclusion Criteria:

1. Age <18 years
2. Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
3. Cardiac failure
4. Active variceal bleeding
5. History of gastroesophageal variceal bleeding
6. Previous TIPS, BRTO, CARTO or PARTO procedure
7. No right jugular or right common femoral venous access
8. No portal vein flow
9. Malignancy
10. Life expectancy of less than 6 months

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Non-selective beta blockers

Non-selective beta blockers prescribed according to standard of care treatment guidelines. These may include propranolol, nadolol, and timolol.

active comparator: Retrograde transvenous obliteration (RTO)

Pre-emptive treatment with retrograde transvenous obliteration

Interventions

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.

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.

Primary outcome measure

  • Episodes of variceal bleeding [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Edward W. Lee, MD, PhD

310-267-8771edwardlee@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Aniket Joglekar

310-948-8026AJoglekar@mednet.ucla.edu

Saima Chaabane, PhD

424-465-4482SChaabane@mednet.ucla.edu

Principal Investigator:

Edward Lee, M.D.

More Information

Sponsor

University of California, Los Angeles

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • varices
  • stomach
  • gastric
  • hepatic encephalopathy
  • gastric variceal bleeding
  • bleeding
  • retrograde transvenous obliteration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.