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New stent technique aims to stop deadly bleeding without harming the brain

NCT ID NCT07253389

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of placing a stent in the liver to prevent repeat bleeding from swollen veins in the throat or stomach in people with cirrhosis. The standard method fully expands the stent, while the new method uses a smaller balloon to keep it slightly narrower. The goal is to see if the narrower stent works just as well to stop bleeding but causes fewer brain problems. About 648 adults in Chinese hospitals will take part.

What this could mean

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

Active substance
Underdilated TIPS procedure using a 6-mm balloon to expand a stent in the liver
What this could lead to
If successful, this could offer a safer way to prevent dangerous variceal rebleeding in cirrhosis patients, with fewer brain side effects.
What could go wrong
This is a mid-stage trial, and the underdilated stent might not prevent rebleeding as well as the standard approach. Results may not apply outside Chinese hospitals.

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 648 people

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

Started

Oct 2025

Expected to finish

Sep 2029

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 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\. Age 18-75 years. 2. Diagnosis of liver cirrhosis according to the 2023 Consensus Opinion on the Clinical Diagnosis and Treatment of Liver Cirrhosis in China (Chinese Society of Gastroenterology). Diagnosis is based on clinical manifestations and imaging findings; histological confirmation is required if the diagnosis remains inconclusive. 3\. High-risk acute variceal bleeding, defined as any of the following: 1. High-risk acute esophageal or type 1 gastroesophageal variceal bleeding, including: Child-Pugh grade B with a score \> 7 and endoscopic evidence of active bleeding; Child-Pugh grade C with a score \< 14. 2. Hepatic venous pressure gradient (HVPG) \> 20 mmHg during bleeding. 3. Early rebleeding within 5 days. 4. Bleeding uncontrolled despite pharmacological and endoscopic therapy. 4. History of esophageal or gastric variceal bleeding with failure of standard first-line treatment \[endoscopy combined with non-selective beta-blockers (NSBB)\]; or first hemorrhage accompanied by grade 2 ascites and/or portal vein thrombosis; GOV2 or IGV1 gastric variceal bleeding; ectopic variceal bleeding; or bleeding from refractory portal hypertensive gastropathy. 5\. Planned TIPS procedure. 6. Ability and willingness to provide written informed consent. Exclusion Criteria: 1. Budd-Chiari syndrome or other causes of non-cirrhotic portal hypertension. 2. Current or prior malignancy, including hepatocellular carcinoma or malignancies of other organs. 3. Complete thrombosis of the main portal vein. 4. Severe psychiatric or neurologic disorders (e.g., uncontrolled epilepsy, dementia). 5. Prior liver resection or liver transplantation. 6. Prior TIPS or surgical portosystemic shunt. 7. Pregnancy or lactation. 8. Any contraindication to TIPS, including: (1) Congestive heart failure (New York Heart Association class C or D, or left ventricular ejection fraction \< 50%). (2) Severe pulmonary hypertension (mean pulmonary artery pressure \> 45 mmHg as measured invasively). (3) Uncontrolled systemic infection. (4) Severe overt hepatic encephalopathy (OHE) with unmodifiable spontaneous portosystemic shunt. 9.Acute hemorrhage with a MELD score ≥ 30 and/or arterial lactate \> 12 mmol/L, or presence of acute-on-chronic liver failure (ACLF). 10\. Systemic conditions requiring ongoing glucocorticoid or nonsteroidal anti-inflammatory drug (NSAID) therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Fourth Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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