An interventional study of Standard Care and Routine Follow-Up and Hepatic Encephalopathy Intelligent Monitoring Mini-Program in Hepatic Encephalopathy and Liver Cirrhosis, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Prevention
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.
Background and Objectives:
Hepatic encephalopathy (HE) is a severe complication following transjugular intrahepatic portosystemic shunt (TIPS) placement, and traditional low-frequency outpatient follow-ups often fail to detect early cognitive decline. Smartphone mini-programs offer a novel, high-frequency tool for dynamic home monitoring. This prospective, multicenter, randomized controlled trial aims to evaluate whether a digital early warning system combined with standardized interventions can reduce the composite endpoint of overt HE, related readmissions, and mortality within 1 month post-TIPS.
Study Population:
We plan to enroll 394 patients with decompensated cirrhosis undergoing elective TIPS across four centers. Eligible subjects must not have overt HE at baseline and must possess basic smartphone skills.
Interventions:
Patients will be randomized 1:1 into two groups:
Intervention Group: Patients will use a customized application for daily cognitive testing and symptom self-assessment for 1 month post-discharge. Abnormal results will trigger automated alerts, prompting the medical team to conduct remote evaluations and provide standardized medical interventions within 4 to 8 hours.
Conventional Follow-up Group: Patients will receive standard discharge care and weekly telephone follow-ups without the application.
Endpoints:
Primary Endpoint: The cumulative incidence of a composite endpoint (first occurrence of overt HE, related unplanned readmission, or all-cause mortality) within 1 month after TIPS.
Secondary Endpoints: The diagnostic accuracy of the application for covert HE, the incidence of TIPS-related complications (e.g., liver failure, shunt dysfunction), and overall survival rates at 3, 6, and 12 months.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's planned enrollment of 394 is above the median of 60 across 154 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard TIPS treatment and discharge instructions, patients in this arm will use a customized smartphone mini-program daily for 1 month post-discharge to complete cognitive function tests and symptom self-assessments. If the system detects cognitive decline or worsening symptoms and triggers an alert, the medical team will respond within a specified timeframe to conduct remote assessments and initiate standardized medical interventions.
Device: Hepatic Encephalopathy Intelligent Monitoring Mini-Program
Patients in this arm will receive standard TIPS treatment, routine discharge health instructions, and weekly telephone follow-ups by the research nurse for 1 month. The follow-ups will include routine symptom inquiries and medication reminders, but these patients will not use the mini-program for quantitative daily cognitive function monitoring.
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.
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.
Cumulative Incidence of the Primary Composite Endpoint
This composite endpoint measures the proportion of patients experiencing their first occurrence of any of the following events: (1) Overt hepatic encephalopathy (OHE), defined as West-Haven grade II or higher; (2) Unplanned hospital readmission due to cirrhosis-related complications or hepatic encephalopathy; or (3) All-cause mortality.
Time frame: 1 month post-TIPS procedure
Frequency and Severity of Overt Hepatic Encephalopathy (OHE) Episodes
Assessing the clinical impact of the early warning system by evaluating the total number of OHE episodes per patient and the West-Haven grade at the first OHE onset.
Time frame: 1 month post-TIPS procedure
Incidence of TIPS-Related Complications and New-Onset Infections
Evaluating clinical safety by monitoring the incidence of new-onset clinical infections (e.g., spontaneous bacterial peritonitis, pulmonary infection) and TIPS-related complications, including acute-on-chronic liver failure, shunt dysfunction, upper gastrointestinal rebleeding, and recurrent ascites.
Time frame: Up to 1 month and 6 months post-TIPS procedure
Overall Survival and Transplant-Free Survival
Comparing the cumulative overall survival rate and transplant-free survival rate between the two groups.
Time frame: At 3, 6, and 12 months post-TIPS procedure
No study locations are listed for this record.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →