UDCA to Prevent Post-TIPS Hepatic Encephalopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ursodeoxycholic Acid (UDCA)
- Lactulose
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
West China Hospital
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
First Affiliated Hospital of Kunming Medical University
Collaborator
Qianjiang Central Hospital of Chongqing
Collaborator
The Third People's Hospital of Kunming City
Collaborator
Source ClinicalTrials.gov