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New trial aims to stop stomach bleeding before it starts

NCT ID NCT07168395

Disease control Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether treating enlarged stomach veins (gastric varices) early with a procedure called retrograde transvenous obliteration (RTO) can prevent dangerous bleeding. 68 adults with cirrhosis and gastric varices will be randomly assigned to either RTO or standard care with beta-blocker medication. Researchers will track bleeding episodes, survival, and complications over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Retrograde transvenous obliteration (RTO) procedure
What this could lead to
If successful, this could offer a way to prevent dangerous stomach variceal bleeding before it starts, potentially reducing emergency treatments and improving survival.
What could go wrong
This is a small, early-phase trial with only 68 participants. The procedure carries risks like bleeding or liver complications, and it may not prove better than current medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver esophageal varices Hemorrhage hepatic encephalopathy varicose disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric varices

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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