Underdilated-stent Technique Improves Post-TIPS Encephalopathy

January 9, 2026 updated by: The Second Affiliated Hospital of Chongqing Medical University

Underdilated-stent Technique Improves Post-transjugular Intrahepatic Portosystemic Shunt Encephalopathy: a Randomized Controlled Trial

Transjugular intrahepatic portosystemic shunt (TIPS) is a critical therapeutic approach for managing esophagogastric variceal bleeding and refractory ascites in decompensated cirrhosis patients. To date, hepatic encephalopathy (HE) remains one of the most common complications following TIPS procedures, and prediction and prevention of post-TIPS HE have always been a hotspot in the field of hepatology. However, no reliable clinical studies have confirmed that any drug or intervention can effectively prevent the occurrence of HE episodes following TIPS, including lactulose and rifaximin.

Underdilated strategy (UDS) was reported as an development technique proposed in recent years for TIPS procedures, which involves using a small-diameter balloon to dilate the puncture tract and subsequently implanted standard-diameter covered stent (e.g., 8 mm). This allows the stent to maintain a smaller diameter shortly after release, thereby reducing the incidence of hepatic encephalopathy during the postoperative period. Over time, the stent gradually dilates to its normal diameter within months. This period coincides with the higher incidence risk of post-TIPS HE, most commonly occurring within 6 months, especially within the first 3 months after TIPS. Therefore, theoretically, UDS can reduce the occurrence of post-TIPS HE. In terms of clinical research, however, there were still no high quality studies reported the advantages of this technique. Current reported clinical studies were all non-randomized controlled trials or retrospective studies, with low-quality evidence and sometimes contradictory findings.

The aim of this prospective randomized controlled clinical study is to evaluate whether administration of underdilated technology during TIPS can improve postoperative hepatic encephalopathy, without compromising the therapeutic efficacy of portal hypertension complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400072
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Yongjun Zhu
      • Qianjiang, Chongqing Municipality, China, 409099
        • Recruiting
        • Qianjiang Central Hospital
        • Contact:
        • Sub-Investigator:
          • Fei Xiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: underdilation group
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.
Device: 6mm balloon dilation
A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.
Active Comparator: full-dilation group
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.
Device: 8mm balloon dilation
A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of overt hepatic encephalopathy
Time Frame: 12 months
West-Haven grade no less than 2.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
remission of complications of portal hypertention
Time Frame: 12 months
variceal rebleeding diagnosed on endoscopy, or worsened ascites diagnosed by ultrasound or CT/MRI.
12 months
liver function
Time Frame: 12 months
Child-Pugh Classification
12 months
liver transplantation-free survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

West China Hospital
Qianjiang Hospital, Chongqing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDS-TIPS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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