Hepatic EncephalopathyNCT07901556
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
A study testing Hepatic Encephalopathy Intelligent Monitoring Mini-Program in people with Hepatic Encephalopathy and Liver Cirrhosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis
- What is being tested?
- Hepatic Encephalopathy Intelligent Monitoring Mini-Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Being tested
- Standard Care and Routine Follow-Up, Hepatic Encephalopathy Intelligent Monitoring Mini-Program
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Early Warning System, Smartphone Application, Telemonitoring, Mobile Health
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care and Routine Follow-UpOther
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.
Hepatic Encephalopathy Intelligent Monitoring Mini-ProgramDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mini-Program Intervention Group | Experimental | 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. Receives: Device: Hepatic Encephalopathy Intelligent Monitoring Mini-Program |
| Conventional Follow-Up Group | Active comparator | 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. Receives: Other: Standard Care and Routine Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-TIPS procedure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 3, 6, and 12 months post-TIPS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, multicenter, parallel randomized controlled trial. Following baseline assessment, eligible patients are randomly assigned in a 1:1 ratio to either the mini-program intervention group or the conventional follow-up control group. Randomization is performed using a random number sequence generated by statistical software. Given the nature of the smartphone-based intervention, it is not feasible to blind the participants or the healthcare providers, making this an open-label study. However, to minimize potential bias, a single-blind method is adopted wherein the outcome assessors and data analysts will remain blinded to the group allocations during endpoint adjudication and statistical analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Zhang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901556
- Sponsor's protocol ID
- PHES-2026-0474-02
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07901556
- Acronym / sponsor ID
- PHES-2026-0474-02
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Keywords
- Transjugular Intrahepatic Portosystemic Shunt, TIPS, Early Warning System, Smartphone Application, Telemonitoring, Mobile Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, multicenter, parallel randomized controlled trial. Following baseline assessment, eligible patients are randomly assigned in a 1:1 ratio to either the mini-program intervention group or the conventional follow-up control group. Randomization is performed using a random number sequence generated by statistical software. Given the nature of the smartphone-based intervention, it is not feasible to blind the participants or the healthcare providers, making this an open-label study. However, to minimize potential bias, a single-blind method is adopted wherein the outcome assessors and data analysts will remain blinded to the group allocations during endpoint adjudication and statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| Mini-Program Intervention Group | Experimental | Device: Hepatic Encephalopathy Intelligent Monitoring Mini-ProgramIn 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. |
| Conventional Follow-Up Group | Active comparator | Other: Standard Care and Routine Follow-UpPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Care and Routine Follow-UpPatients 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. | Other | Conventional Follow-Up Group |
| Hepatic Encephalopathy Intelligent Monitoring Mini-ProgramThe 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. | Device | Mini-Program Intervention Group |
Primary outcome
Cumulative Incidence of the Primary Composite Endpoint
Time frame: 1 month post-TIPS procedure
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.
3 secondary outcomes
Frequency and Severity of Overt Hepatic Encephalopathy (OHE) Episodes
Time frame: 1 month post-TIPS procedure
Incidence of TIPS-Related Complications and New-Onset Infections
Time frame: Up to 1 month and 6 months post-TIPS procedure
Overall Survival and Transplant-Free Survival
Time frame: At 3, 6, and 12 months post-TIPS procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic Encephalopathy Intelligent Monitoring Mini-Program in people with Hepatic Encephalopathy and Liver Cirrhosis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Zhang (13961872835, fzdndx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of the Primary Composite Endpoint (time frame: 1 month post-TIPS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.