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NCT07901556

Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This study is a prospective, multicenter, randomized controlled clinical trial. It aims to evaluate whether an early monitoring and warning system based on a smartphone mini-program can effectively reduce the incidence of overt hepatic encephalopathy (OHE) and the risk of related readmission or death in cirrhotic patients within 1 month after transjugular intrahepatic portosystemic shunt (TIPS) placement. Patients with decompensated cirrhosis are at high risk of developing hepatic encephalopathy after TIPS. The traditional follow-up model often fails to capture subtle fluctuations in early neuropsychiatric symptoms during the home care period. This study plans to recruit 394 patients undergoing elective TIPS. These patients will be randomly assigned to either the mini-program intervention group or the conventional follow-up group in a 1:1 ratio. In addition to standard treatment, the intervention group will undergo daily cognitive function testing and symptom self-assessment using a dedicated mini-program for 1 month after discharge. When the system detects abnormal cognitive indicators or symptom deterioration and triggers an alert, the medical team will respond rapidly and initiate standardized interventions. The conventional follow-up group will receive standard discharge instructions and weekly telephone follow-ups. This study aims to establish a closed-loop digital management model of "home self-monitoring - intelligent early warning - medical intervention" to achieve early identification and timely intervention for covert hepatic encephalopathy, thereby tangibly improving the clinical prognosis of patients after TIPS.

Official title: Effect of a Mini-Program-Based Early Monitoring Strategy on the Incidence of Overt Hepatic Encephalopathy in Patients After Transjugular Intrahepatic Portosystemic Shunt: A Prospective, Multicenter, Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

394

Start Date

2026-10

Completion Date

2028-08

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Hepatic Encephalopathy Liver Cirrhosis

Interventions

OTHER

Standard Care and Routine Follow-Up

Patients in this group will receive standard medical care and conventional follow-up after TIPS placement. This includes routine discharge health instructions and standard weekly telephone follow-ups by the research nurse for 1 month to inquire about symptoms and provide medication reminders. They will not use the dedicated smartphone mini-program for cognitive monitoring.

DEVICE

Hepatic Encephalopathy Intelligent Monitoring Mini-Program

The intervention utilizes a customized WeChat-based mini-program for the early monitoring of hepatic encephalopathy. Patients log in daily (08:00-16:00) for 1 month post-discharge to complete cognitive tests and symptom self-assessments. Abnormal results trigger automatic alerts, prompting the medical team to respond within 4-8 hours to conduct remote assessments and provide standardized medical interventions.

Inclusion Criteria: * Aged 18 to 75 years. * Confirmed diagnosis of liver cirrhosis (based on clinical, laboratory, imaging, or histological findings) and successfully treated with elective transjugular intrahepatic portosystemic shunt (TIPS) for esophagogastric variceal bleeding (EGVB) or refractory ascites. * Intact baseline cognitive status without overt hepatic encephalopathy (OHE, West-Haven grade \< II) pre- or post-procedure, and able to cooperate with neuropsychological testing. * The patient and their primary caregiver possess a smartphone, are proficient in using WeChat and mini-programs, and have access to a stable network environment. * Voluntarily signed informed consent, demonstrating good compliance, and fully understanding the study protocol. * Estimated life expectancy greater than 1 year. Exclusion Criteria: * Presence of malignant tumors. * Concomitant autoimmune diseases. * Severe jaundice (serum total bilirubin \>= 85 umol/L) or marked renal insufficiency (serum creatinine \>= 1.2 x upper limit of normal). * Neuropsychiatric confounding factors: history of non-liver-related neuropsychiatric disorders (e.g., Alzheimer's disease, Parkinson's disease, stroke sequelae, severe depression/anxiety, schizophrenia) or current use of antidepressants/antipsychotics that could confound cognitive assessments; severe visual or auditory impairment preventing smartphone use; or severe alcohol dependence/substance abuse unable to cooperate with abstinence. * Absolute contraindications to TIPS: severe right heart failure, congestive heart failure (ejection fraction \< 40%), severe valvular heart disease, persistent severe pulmonary arterial hypertension (mean pulmonary arterial pressure \> 45 mmHg), uncontrolled systemic infection, or stage III-IV hepatic encephalopathy. * Women who are pregnant, planning pregnancy, or breastfeeding. * Unwillingness to participate or inability to provide informed consent. * Any other condition judged by the investigator to interfere with study evaluation, increase participant risk, or compromise study completion. * Participation in other clinical trials within the past 3 months or currently enrolled in another trial.