Recruiting

Underdilated-Stent Technique for Post-TIPS Encephalopathy Improvement

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What is being tested

6mm balloon dilation

+ 8mm balloon dilation

Device
Who is being recruted

Brain Diseases+12

+ Brain Diseases, Metabolic

+ Central Nervous System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorThe Second Affiliated Hospital of Chongqing Medical University
Study ContactYongjun Zhu, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 19, 2024

Actual date on which the first participant was enrolled.

Transjugular intrahepatic portosystemic shunt (TIPS) is a vital treatment for managing bleeding in the esophagus and stomach, as well as stubborn fluid build-up in the abdomen due to liver cirrhosis. However, a common complication after this procedure is hepatic encephalopathy (HE), a condition that affects the brain. Currently, no reliable studies have found a drug or intervention that can effectively prevent HE after TIPS, including drugs like lactulose and rifaximin. This study focuses on a new technique called Underdilated Strategy (UDS). UDS uses a smaller balloon to expand the tract and then places a standard-sized covered stent. This allows the stent to maintain a smaller size initially, potentially reducing the risk of HE after the procedure. Over time, the stent gradually expands to its normal size. The study aims to evaluate if UDS can improve post-operative HE without affecting the treatment's effectiveness for portal hypertension complications.

Official TitleUnderdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial
Principal SponsorThe Second Affiliated Hospital of Chongqing Medical University
Study ContactYongjun Zhu, Doctor
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesDigestive System DiseasesFibrosisHepatic EncephalopathyLiver CirrhosisLiver DiseasesMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic Insufficiency

Criteria

Inclusion Criteria: * Liver cirrhosis, defined by clinical manifestations, biochemical indicators, imaging examinations, or liver biopsy; * History of esophagogastric variceal bleeding, or refractory/recurrent ascites; * Intended to undergo TIPS treatment. Exclusion Criteria: * Non-cirrhotic portal hypertension; * Previous treatments that may affect portal pressure, such as TIPS or surgical procedures; * History of overt hepatic encephalopathy (West-Haven classification ≥2); * Malignant tumors in advanced stages; * Concomitant irreversible heart, liver, kidney, or respiratory failure; * Unable or unwilling to sign the informed consent form.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients in this group will receive a underdilated strategy during TIPS procedure by using a 6mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.

Group II

Active Comparator
Patients in this group will receive a fully-dilated strategy during TIPS procedure by using a 8mm balloon to dilate the puncture tract and subsequently implanted 8mm Viatorr stent.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, ChinaOpen The Second Affiliated Hospital of Chongqing Medical University in Google Maps
Recruiting

Qianjiang Central Hospital

Qianjiang, China
Recruiting
2 Study Centers