New stent technique aims to stop deadly bleeding without harming the brain
NCT ID NCT07253389
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
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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
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About 648 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fourth Military Medical University
RECRUITINGXi'an, Shaanxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria in a capsule: a new attempt to calm a brain complication of cirrhosis
- Can a digital platform catch liver cancer sooner?
- Can a Two-Drug combo keep cirrhosis patients out of the hospital?
- Can removing the spleen help the liver fight cancer?
- Blood test may forecast which cirrhosis patients survive after discharge
- Can a parasite drug help fight a deadly gut infection in cirrhosis?