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UDCA to Prevent Post-TIPS Hepatic Encephalopathy

NCT07273734 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-12-09

No results posted yet for this 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.

Conditions

  • Hepatic Encephalopathy (HE)
  • TIPS

Interventions

DRUG

Ursodeoxycholic Acid (UDCA)

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

DRUG

Lactulose

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

Sponsors & Collaborators

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Qianjiang Central Hospital of Chongqing

    collaborator UNKNOWN

  • The Third People's Hospital of Kunming City

    collaborator UNKNOWN

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273734 on ClinicalTrials.gov