Liver CirrhosisNCT07437638
Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis and Hepatic Encephalopathy, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement. A retrospective analysis will be conducted on medical records of 624 cirrhotic patients who underwent TIPS from 2011 to 2021. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy, TIPS
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 5 Apr 2026
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included 624 patients with liver cirrhosis who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between May 2011 and December 2021
Who may be able to join
- Age 18-80 years, regardless of gender
- Diagnosis of decompensated cirrhosis meeting clinical guidelines
- Complete preoperative baseline data available, with regular postoperative follow-up for at least 3 months to assess endpoint events
- Absence of absolute contraindications for TIPS
Who cannot join
- Age < 18 or > 80 years
- Non-cirrhotic portal hypertension
- Hepatocellular carcinoma or other systemic malignancies
- Severe cardiopulmonary disease
- Prior liver transplantation or portosystemic shunt surgery
- Death or liver transplantation within 30 days post-TIPS
- Missing key baseline data or loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement. A retrospective analysis will be conducted on medical records of 624 cirrhotic patients who underwent TIPS from 2011 to 2021. Statistical methods will be applied to screen preoperative routine indicators associated with post-TIPS hepatic encephalopathy risk. A predictive nomogram will be constructed incorporating the screened indicators to estimate individual preoperative risk. The predictive performance will be compared with conventional clinical scoring systems. This tool is intended to facilitate preoperative risk evaluation and targeted management of high-risk patients undergoing TIPS
Read the detailed description
Background: Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for the complications of portal hypertension. However, hepatic encephalopathy remains a major complication after TIPS, and its independent risk factors are not fully elucidated. The purpose of this study is to investigate the independent risk factors of hepatic encephalopathy (HE) after TIPS in patients with liver cirrhosis, and to construct a nomogram model to identify high-risk patients before TIPS.
Method: This retrospective study will include cirrhotic patients who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between 2011 and 2021. Patients will be randomly split into training (70%) and validation (30%) cohorts. Predictors will be selected using LASSO regression with cross-validation and further analyzed via multivariable logistic regression to build a nomogram. Model performance will be evaluated and compared with conventional scores (MELD, MELD-Na, ALBI, FIPS).
Result: To be reported after study completion. Conclusion: A nomogram based on routine preoperative variables is hypothesized to predict HE risk after TIPS. This study intends to provide a tool for preoperative risk stratification and individualized patient management.
Keywords: cirrhosis; transjugular intrahepatic portosystemic shunt; hepatic encephalopathy; prognosis; nomogram
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, TIPS
- Keywords
- cirrhosis, transjugular intrahepatic portosystemic shunt, hepatic encephalopathy, prognosis, nomogram
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HE Group | Cirrhotic patients who underwent TIPS and were subsequently diagnosed with hepatic encephalopathy within 3 months after the procedure, as identified through a retrospective review of electronic medical records. | |
| Non-HE Group | Cirrhotic patients who underwent TIPS and remained free from a diagnosis of hepatic encephalopathy throughout the 3-month follow-up period after the procedure, as confirmed by retrospective review of medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hepatic encephalopathy within 3 months after TIPS
The development of hepatic encephalopathy, diagnosed based on clinical assessment and medical records during follow-up outpatient visits or hospital readmissions within 3 months after the TIPS procedure. All HE cases in this study occurred within this period.
Measured: 3-month follow-up after TIPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Sep 2024
- Primary completion5 Apr 2026 (estimated)
- Study completion5 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Kang, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437638
- Sponsor's protocol ID
- 2024IIT049
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected for this observational study contain sensitive personal health information (e.g., detailed clinical outcomes and laboratory results). To protect participant privacy and confidentiality in accordance with local data protection regulations and the approved ethics protocol, the datasets will not be publicly deposited. Data are owned by the chongqing Medical University and may be available upon reasonable request to the corresponding author for purposes of verification or collaborative research, subject to a formal data sharing agreement and institutional approvals.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07437638
- Acronym / sponsor ID
- 2024IIT049
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, TIPS
- Keywords
- cirrhosis, transjugular intrahepatic portosystemic shunt, hepatic encephalopathy, prognosis, nomogram
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 624 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 5 Apr 2026 (estimated)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 27 Feb 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 aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement. A retrospective analysis will be conducted on medical records of 624 cirrhotic patients who underwent TIPS from 2011 to 2021. Statistical methods will be applied to screen preoperative routine indicators associated with post-TIPS hepatic encephalopathy risk. A predictive nomogram will be constructed incorporating the screened indicators to estimate individual preoperative risk. The predictive performance will be compared with conventional clinical scoring systems. This tool is intended to facilitate preoperative risk evaluation and targeted management of high-risk patients undergoing TIPS
Detailed description
Background: Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for the complications of portal hypertension. However, hepatic encephalopathy remains a major complication after TIPS, and its independent risk factors are not fully elucidated. The purpose of this study is to investigate the independent risk factors of hepatic encephalopathy (HE) after TIPS in patients with liver cirrhosis, and to construct a nomogram model to identify high-risk patients before TIPS.
Method: This retrospective study will include cirrhotic patients who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between 2011 and 2021. Patients will be randomly split into training (70%) and validation (30%) cohorts. Predictors will be selected using LASSO regression with cross-validation and further analyzed via multivariable logistic regression to build a nomogram. Model performance will be evaluated and compared with conventional scores (MELD, MELD-Na, ALBI, FIPS).
Result: To be reported after study completion. Conclusion: A nomogram based on routine preoperative variables is hypothesized to predict HE risk after TIPS. This study intends to provide a tool for preoperative risk stratification and individualized patient management.
Keywords: cirrhosis; transjugular intrahepatic portosystemic shunt; hepatic encephalopathy; prognosis; nomogram
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HE Group | – | –Cirrhotic patients who underwent TIPS and were subsequently diagnosed with hepatic encephalopathy within 3 months after the procedure, as identified through a retrospective review of electronic medical records. |
| Non-HE Group | – | –Cirrhotic patients who underwent TIPS and remained free from a diagnosis of hepatic encephalopathy throughout the 3-month follow-up period after the procedure, as confirmed by retrospective review of medical records |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included 624 patients with liver cirrhosis who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between May 2011 and December 2021
Key inclusion criteria (4 listed)
- Age 18-80 years, regardless of gender
- Diagnosis of decompensated cirrhosis meeting clinical guidelines
- Complete preoperative baseline data available, with regular postoperative follow-up for at least 3 months to assess endpoint events
- Absence of absolute contraindications for TIPS
Key exclusion criteria (7 listed)
- Age < 18 or > 80 years
- Non-cirrhotic portal hypertension
- Hepatocellular carcinoma or other systemic malignancies
- Severe cardiopulmonary disease
- Prior liver transplantation or portosystemic shunt surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of hepatic encephalopathy within 3 months after TIPS
Time frame: 3-month follow-up after TIPS
The development of hepatic encephalopathy, diagnosed based on clinical assessment and medical records during follow-up outpatient visits or hospital readmissions within 3 months after the TIPS procedure. All HE cases in this study occurred within this period.
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 27 Feb 2026.
- Individual participant dataSharing planned: No. The individual participant data collected for this observational study contain sensitive personal health information (e.g., detailed clinical outcomes and laboratory results). To protect participant privacy and confidentiality in accordance with local data protection regulations and the approved ethics protocol, the datasets will not be publicly deposited. Data are owned by the chongqing Medical University and may be available upon reasonable request to the corresponding author for purposes of verification or collaborative research, subject to a formal data sharing agreement and institutional approvals.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Hepatic Encephalopathy, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of hepatic encephalopathy within 3 months after TIPS (time frame: 3-month follow-up after TIPS). 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 27 Feb 2026.