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Rifaximin for the prevention of overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with minimal hepatic encephalopathy: A randomized controlled study

Rifaximin for the prevention of overt hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with minimal hepatic encephalopathy: A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120985
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis, hepatic encephalopathy

Interventions

Rifaximin experimental group:Rifaximin and basic nutritional support
Placebo control group:Placebo and basic nutritional support

Sponsors

Zhongda Hospital, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old; 2.Diagnosed with liver cirrhosis; 3.Underwent TIPS surgery within one month due to esophageal-gastric variceal rupture bleeding, refractory ascites, etc.; 4.Diagnosed with MHE (i.e., PHES score < -4) before the TIPS surgery; 5.Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Previous or current West-Haven classification >= Grade II; 2.Uncontrolled acute gastric esophageal variceal rupture bleeding (salvage TIPS); 3.Contraindications for TIPS: severe right heart failure, congestive heart failure (ejection fraction 35 mmHg); uncontrolled intrahepatic or systemic infection; Child Pugh score > 14 or MELD score > 30; organic kidney disease with renal insufficiency (estimated glomerular filtration rate 5, or platelets < 20 × 10^9/L); biliary obstruction; polycystic liver; portal vein cavernous transformation combined with superior mesenteric vein embolism; liver cirrhosis-related cardiomyopathy, etc.; 4.Proven hepatocellular carcinoma by imaging examination; 5.Allergic to rifaximin and its corresponding preparations; 6.Need to use other antibiotics in addition to rifaximin, and cannot discontinue the medication; 7.Pregnant or lactating women; 8.Have already undergone liver transplantation.

Design outcomes

Primary

MeasureTime frame
The occurrence of overt hepatic encephalopathy;—

Secondary

MeasureTime frame
Adverse events and serious adverse events;The occurrence rate of complications related to portal hypertension;Transplantation rate;Postoperative quality of life;Readmission rate;Neuropsychological test;Death rate;—

Countries

China

Contacts

Public ContactXiaolong Qi

Zhongda Hospital, Southeast University

qixiaolong@vip.163.com+86 25 83272015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026