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Liver cirrhosis bleeding: which procedure wins?

NCT ID NCT07490405

Disease control Sponsor: Northern Jiangsu People's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two procedures for people with liver cirrhosis who have severe bleeding from enlarged veins in the esophagus and an enlarged spleen. One procedure removes the spleen and disconnects certain veins (LSD), while the other places a shunt inside the liver (TIPS). The main goal is to see which procedure causes fewer brain complications. The trial will follow 140 participants for long-term outcomes like survival and re-bleeding.

What this could mean

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

Active substance
laparoscopic splenectomy and azygoportal disconnection (LSD) or transjugular intrahepatic portosystemic shunt (TIPS)
What this could lead to
If this trial succeeds, it could show which procedure is safer and more effective for controlling bleeding and preventing brain complications in people with liver cirrhosis.
What could go wrong
This is a single-center trial with only 140 participants, so results may not apply to everyone. Both procedures carry risks like infection, bleeding, or liver problems.

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.

Participants

About 140 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Apr 2036

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.

Who is studied

Cirrhotic portal hypertension with acute esophagogastric variceal bleeding and hypersplenism

Ages

18 to 75 years

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. Confirmed diagnosis of cirrhotic portal hypertension. 2. Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment.. 3. Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia. 4. Liver function Child-Pugh class A or B (score 7-9). 5. Age 18-75 years. 6. Patient provides written informed consent. Exclusion Criteria: 1. Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score \>18. 2. Severe right heart failure or pulmonary hypertension. 3. Uncontrolled systemic infection or sepsis. 4. Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation). 5. Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies. 6. Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication. 7. Severe contrast agent allergy (affecting TIPS procedure). 8. Pregnancy or lactation. 9. Any severe non-hepatic disease with a life expectancy \<1 year. 10. Recent gastric and duodenal ulcers. 11. Inability to comply with follow-up or provide informed consent.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

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

Liver cirrhosis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000, China

More trials for these conditions

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