New stent technique could reduce deadly rebleeding in liver cirrhosis
NCT ID NCT07587671
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
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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 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
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: * 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.
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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
3 sites. 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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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 610041, China
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West China Hospital, Sichuan University
Chengdu, 610041, China
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West China Xiamen Hospital, Sichuan University
Xiamen, 610041, 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
- Ultrasound may replace invasive test for dangerous liver complication
- Can a digital platform catch liver cancer sooner?
- Can a Two-Drug combo keep cirrhosis patients out of the hospital?
- A needle through the gut could replace the standard liver pressure test
- Spleen surgery may reshape cholesterol in cirrhosis