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Early liver shunt may reduce need for repeated fluid drains in ascites patients

NCT ID NCT04315571

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial compares two approved treatments for ascites (fluid buildup in the belly) caused by portal hypertension. One group receives large-volume paracentesis (draining fluid with a needle) plus albumin infusion, while the other gets an early TIPS procedure, which creates a new path in the liver to reduce pressure. The study measures how often paracentesis is needed and whether patients survive without needing a liver transplant.

What this could mean

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

Active substance
Gore® Viatorr® Endoprosthesis (TIPS device)
What this could lead to
If early TIPS works better than repeated fluid drainage, it could reduce the need for frequent paracentesis and improve survival without a liver transplant.
What could go wrong
This is a small, early-stage study (68 people), so results may not apply to everyone. TIPS carries risks like infection, bleeding, or worsening liver function.

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

68 people

The number who actually took part.

Started

Mar 2020

Finished

Apr 2026

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: * Males and females \> 18 years of age at time of procedure * First de novo TIPS placement * Patent internal or external jugular vein * Willing to provide the hepatology service information for follow up * No known diagnosis of hypercoagulopathy * No portal vein thrombosis * No malignancy (must be a definite diagnosis) * Patient must provide written informed consent * Proper clinical indication of TIPS based on American Association for the Study of Liver Diseases (AASLD) guidelines * Recurrent ascites necessitating at least 2 large volume paracenteses performed within a minimum interval of 3 weeks Exclusion Criteria: * Age \<18 * LVP \> 6 times in 2 months * Liver failure (Child Pugh \> 12) * Cardiac failure * No right jugular venous access * Absolute TIPS contraindications (e.g. right heart failure, severe encephalopathy, liver failure, pregnant (if possible)).

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Conditions

The condition(s) this trial relates to.

Ascites End Stage Liver Disease Fibrosis hepatic encephalopathy portal hypertension

As listed by the trial registrant

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

Ascites Hypertension, portal

Contacts and locations

Locations

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.