Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New stent technique could reduce deadly rebleeding in liver cirrhosis

NCT ID NCT07587671

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares a new procedure using a special stent (underdilated VCX-TIPS) with standard treatment (endoscopic banding plus beta-blockers) to prevent variceal rebleeding in people with cirrhosis. The new approach uses a smaller balloon to expand the stent, aiming to lower pressure in the liver's blood vessels while reducing side effects like brain confusion. 240 participants who have recovered from a first variceal bleed will be randomly assigned to one of the two treatments and followed for one year to see which better prevents death or rebleeding.

What this could mean

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

Active substance
Underdilated VIATORR Controlled Expansion stent (a device placed in the liver to reduce pressure in blood vessels)
What this could lead to
If successful, this could offer a more effective way to prevent dangerous rebleeding from varices in cirrhosis patients, potentially reducing deaths and the need for repeat procedures.
What could go wrong
This is an early-stage trial with only 240 participants, so results may not apply to all patients. The underdilated stent might still cause liver problems or brain confusion (hepatic encephalopathy), and the procedure carries risks like any invasive surgery.

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 240 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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: * Age 18 to 75 years, regardless of sex. * Diagnosis of liver cirrhosis based on previous histology, imaging, laboratory tests, and/or clinical manifestations. * Hospitalization for acute upper gastrointestinal bleeding, with endoscopic confirmation that the bleeding is related to esophageal varices or type 1 gastroesophageal varices. * Successful control of acute bleeding after standard acute-phase treatment, with stable vital signs and entry into the secondary prophylaxis phase. * Child-Pugh score of 5 to 13. * The investigator judges that both underdilated VCX-TIPS and EVL plus NSBB are clinically feasible and that randomization is appropriate. * The participant or legally authorized representative understands the study procedures and voluntarily signs written informed consent. Exclusion Criteria: * Hemodynamic instability, persistent active bleeding, or need for immediate rescue TIPS, surgical hemostasis, or interventional radiologic hemostasis. * A strong current indication for early or pre-emptive TIPS that makes randomization to EVL plus NSBB clinically inappropriate. * Child-Pugh score greater than 13. * Previous TIPS, surgical portosystemic shunt, BRTO, CARTO, PARTO, or other procedures that substantially alter portosystemic blood flow. * Isolated gastric varices, type 2 gastroesophageal varices, ectopic varices, or a bleeding source other than esophageal varices or type 1 gastroesophageal varices. * Non-cirrhotic portal hypertension. * Cavernous transformation of the portal vein or portal venous thrombosis that makes standardized TIPS technically infeasible. * Previous recurrent or refractory overt hepatic encephalopathy, or a history of West Haven grade II to IV overt hepatic encephalopathy unrelated to gastrointestinal bleeding. * Severe heart failure, severe pulmonary hypertension, severe tricuspid regurgitation, right heart failure, or other contraindications to TIPS. * Uncontrolled severe infection, sepsis, or multiple organ failure. * Hepatocellular carcinoma beyond the Milan criteria or other advanced malignancy. * Severe renal insufficiency requiring long-term renal replacement therapy. * Pregnancy or breastfeeding. * Absolute contraindication to EVL, NSBB, or TIPS. * Any condition that, in the investigator's judgment, makes the participant unsuitable for the study or unable to complete follow-up.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Esophageal varices are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

    3 sites. 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

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 610041, China

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • West China Xiamen Hospital, Sichuan University

    Xiamen, 610041, China

More trials for these conditions

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