Chinese Registry on Transjugular Intrahepatic Portosystemic Shunts (CN‐TIPS): Protocol for a Registry‐Based, Prospective Prognostic Study

ABSTRACT Aims Transjugular intrahepatic portosystemic shunt (TIPS) is an established treatment for complications of portal hypertension in patients with cirrhosis. Despite advances in technique, challenges remain, including variability in procedural workflows, inadequate perioperative management, and limited high‐quality clinical data. This registry is designed to integrate perioperative clinical, imaging, and multi‐omics data to improve risk stratification, guide individualized management, reduce complications, and enhance transplant‐free survival. Methods This multicenter, prospective cohort study will enroll 10,000 adult patients aged 18–75 years with portal hypertension undergoing TIPS at multiple tertiary hospitals in China between 2025 and 2027. Participants will be followed for 2 years after the procedure. The primary outcome will be transplant‐free survival at 2 years. Secondary outcomes include early portosystemic pressure gradient, improvement in portal hypertension‐related complications, the predictive accuracy of computational fluid dynamics simulations, complication rates, and recurrence of portal hypertension‐related complications. Improvement in liver function will also be assessed using serum biomarkers at 3, 6, 12, and 24 months after TIPS. Imaging data will be collected from 3000 patients, with an additional 1000 undergoing multi‐omics analyses. Statistical methods will include Kaplan–Meier survival analysis, Cox proportional hazards regression, and multivariate modeling. Discussion This registry will provide high‐quality, contemporary real‐world evidence to inform standardized TIPS practice and improve prognostic assessment in a large Chinese population. The integrated clinical, hemodynamic, imaging, and multi‐omics framework may enable refined risk stratification and more individualized post‐TIPS management to improve long‐term outcomes. Trial Registration ChiCTR2500105039.

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Publication Details

Journal
Portal hypertension & cirrhosis
Published
2026-03-03
DOI
https://doi.org/10.1002/poh2.70039
Primary Topic
Liver Disease and Transplantation
Type
article
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article

Chinese Registry on Transjugular Intrahepatic Portosystemic Shunts (CN‐TIPS): Protocol for a Registry‐Based, Prospective Prognostic Study

Yong Lv, Guo Han, Guangchuan Wang, Beijia Yu et al.
Portal hypertension & cirrhosis
Liver Disease and Transplantation
article

Chinese Registry on Transjugular Intrahepatic Portosystemic Shunts (CN‐TIPS): Protocol for a Registry‐Based, Prospective Prognostic Study

Yong Lv, Guo Han, Guangchuan Wang, Beijia Yu, Tianyu Liu, Jiawei Zhang, Jun Chi, He Zhao, Gao‐Jun Teng, Yi Xiang, Wuhua Guo, Meng Niu, H F Zhou, W. Zhou, Wenjing Liu, Jiacheng Liu, Zhang Zhang, Qi Zhang, Long Gao, Xiaolong Qi, Jianbo Zhao
article en

Abstract

ABSTRACT Aims Transjugular intrahepatic portosystemic shunt (TIPS) is an established treatment for complications of portal hypertension in patients with cirrhosis. Despite advances in technique, challenges remain, including variability in procedural workflows, inadequate perioperative management, and limited high‐quality clinical data. This registry is designed to integrate perioperative clinical, imaging, and multi‐omics data to improve risk stratification, guide individualized management, reduce complications, and enhance transplant‐free survival. Methods This multicenter, prospective cohort study will enroll 10,000 adult patients aged 18–75 years with portal hypertension undergoing TIPS at multiple tertiary hospitals in China between 2025 and 2027. Participants will be followed for 2 years after the procedure. The primary outcome will be transplant‐free survival at 2 years. Secondary outcomes include early portosystemic pressure gradient, improvement in portal hypertension‐related complications, the predictive accuracy of computational fluid dynamics simulations, complication rates, and recurrence of portal hypertension‐related complications. Improvement in liver function will also be assessed using serum biomarkers at 3, 6, 12, and 24 months after TIPS. Imaging data will be collected from 3000 patients, with an additional 1000 undergoing multi‐omics analyses. Statistical methods will include Kaplan–Meier survival analysis, Cox proportional hazards regression, and multivariate modeling. Discussion This registry will provide high‐quality, contemporary real‐world evidence to inform standardized TIPS practice and improve prognostic assessment in a large Chinese population. The integrated clinical, hemodynamic, imaging, and multi‐omics framework may enable refined risk stratification and more individualized post‐TIPS management to improve long‐term outcomes. Trial Registration ChiCTR2500105039.

Portal hypertension & cirrhosis
Fujian Medical University (CN), Union Hospital (HK), Shanxi Medical University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), National Cancer Center (US), National Clinical Research Center for Digestive Diseases (CN), Suizhou Central Hospital (CN), Nanfang Hospital (CN), Zhongda Hospital Southeast University (CN), Mengchao Hepatobiliary Hospital (CN), Shandong Provincial Hospital (CN), Zhujiang Hospital (CN), First Hospital of Shanxi Medical University (CN), First Affiliated Hospital of Gannan Medical University (CN), Jiangsu Province Hospital (CN), Guangdong Provincial Center for Disease Control and Prevention (CN), Guangdong Provincial People's Hospital (CN), Tang Du Hospital (CN), Xijing Hospital (CN), Shandong First Medical University (CN), Medical Technologies (Czechia) (CZ), Huazhong University of Science and Technology (CN), Southern Medical University (CN), Southeast University (CN), Nanjing Medical University (CN), China Medical University (CN), Air Force Medical University (CN)
Openalex Percentile: Top 33%
Liver Disease and Transplantation
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