Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms TIPS

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chongqing

Chongqing, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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