Ireland
--:--IST
Starting soon Not applicable

UDCA to Prevent Post-TIPS Hepatic Encephalopathy

NCT07273734 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2025-12-09

Condition(s) studied

Hepatic Encephalopathy (HE)TIPS

Investigational drug(s) / intervention(s)

Ursodeoxycholic Acid (UDCA) →Lactulose →

Ursodeoxycholic Acid (UDCA): 13-15 mg/kg/day orally, in divided doses (BID), starting ≤72 hours before TIPS and continued for 3 months.

Lactulose: Syrup 25 mL BID, initiated after TIPS procedure, titrated to 1-2 soft stools/day, with dose reduction if diarrhea occurs.

Study summary

Hepatic encephalopathy (HE) commonly occurs after transjugular intrahepatic portosystemic shunt (TIPS). Ursodeoxycholic acid (UDCA) has been reported to alleviate neurodegenerative disease recently. This open-label multicenter randomized controlled trial tests whether adding UDCA (13-15 mg/kg/day) to standard lactulose prophylaxis reduces the incidence of overt HE (OHE; West Haven grade II-IV) after TIPS, compared with lactulose alone. The regimen starts within 72 hours before TIPS and continues for 3 months. The trial aims to evaluate the effect of UDCA in reducing the incidence of post-TIPS OHE.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-80 years. * Confirmed cirrhosis (biopsy, elastography, or standard radiologic/biochemical criteria). * Elective TIPS for (a) refractory/recurrent ascites and/or (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers. * Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg. * Ability to start study drug within 72 hours before TIPS. * Signed informed consent. Exclusion Criteria: * Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score \>13, main-trunk PVT if not recanalizable, technical infeasibility). * Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's). * Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months. * Current/recent rifaximin use (\<3 months) or strong UDCA contraindication/hypersensitivity. * Salvage TIPS. * Non-cirrhotic portal hypertension. * Pregnancy/lactation. * Any condition that, in investigators' judgment, precludes safe participation.

Primary outcome measure(s)

  • Incidence of Overt Hepatic Encephalopathy (OHE) within 3 Months After TIPS — From TIPS procedure (Day 0) to 3 months post-TIPS (Day 90).
    OHE defined as first occurrence of West Haven grade II-IV hepatic encephalopathy within 3 months after covered TIPS, adjudicated by investigator assessment according to West Haven criteria.

Trial sites (1)

FacilityCityRegionStatus
West China Hospital, Sichuan University Chengdu China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07273734 on ClinicalTrials.gov ↗ ← All trials in China