UDCA to Prevent Post-TIPS Hepatic Encephalopathy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | China |
More West China Hospital trials in China
Other trials for the same condition
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