NCT07437638

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 624 (actual)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Liver Cirrhosis
• Hepatic Encephalopathy
• TIPS

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-04-05
• Completion: 2026-04-05
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China