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NCT Number: NCT07349654

Underdilated-stent Technique Improves Post-TIPS Encephalopathy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

6mm balloon dilation

Device

A 6mm balloon was used to under-dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.

8mm balloon dilation

Device

A standard 8mm balloon was used to fully dilate the puncture puncture tract and subsequently implanted 8mm Viatorr stent during TIPS procedure.

Primary outcomes

  1. incidence of overt hepatic encephalopathy

    Time frame: 12 months

    West-Haven grade no less than 2.

Secondary outcomes

  1. remission of complications of portal hypertention

    Time frame: 12 months

    variceal rebleeding diagnosed on endoscopy, or worsened ascites diagnosed by ultrasound or CT/MRI.

  2. liver function

    Time frame: 12 months

    Child-Pugh Classification

  3. liver transplantation-free survival

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Yongjun Zhu, Doctor

CONTACT

[email protected]

86-13281121937

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Collaborators

  • Qianjiang Hospital, Chongqing University
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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