The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis

Official title

Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Recompensation in Patients With Decompensated Cirrhosis: A Multicenter Prospective Cohort Study

Overview

The traditional view holds that the natural course of cirrhosis is a unidirectional process, characterized by irreversible progression from the compensated stage to the decompensated stage, and is highly likely to develop further decompensation events or even death. However, a growing body of evidence suggests that the natural course of cirrhosis is not always unidirectional - after the removal of the etiology, the structural and functional changes of the liver may be partially reversed. This understanding has given rise to the concept of "liver recompensation," which has been standardized at the Baveno VII Consensus Conference. Notably, in a cohort of patients with alcohol-related cirrhosis, 18% achieved recompensation, which was significantly associated with a reduction of more than 90% in liver-related mortality. In patients with hepatitis B-related cirrhosis, 6% achieved recompensation after treatment with nucleos(t)ide analogs, with a similar improvement in mortality. Transjugular intrahepatic portosystemic shunt (TIPS) is a well-established therapy for complications related to portal hypertension, including gastroesophageal variceal bleeding, refractory ascites, and hepatic hydrothorax. Compared with standard treatment, TIPS has been proven to reduce the incidence of further decompensation and improve transplant-free survival. However, due to portal blood shunting, the risks of abnormal liver function and hepatic encephalopathy (HE) also increase. It is worth noting that TIPS is not included in the definition of recompensation in the Baveno VII Consensus. Therefore, whether patients with cirrhosis who undergo TIPS treatment can achieve recompensation and which factors determine the probability of recompensation remain unknown. More importantly, the impact of recompensation on the risk of HCC development and mortality in TIPS patients has not been studied prospectively.

Primary outcome measures

• 1-year post-TIPS recompensation rate [Time frame: 1 year]

Secondary outcome measures (3)

• Identification of factors associated with recompensation at 1 year after TIPS [Time frame: 1 year]
• Impact of recompensation on the risk of hepatocellular carcinoma (HCC) development [Time frame: 1 year]
• Impact of recompensation after Transjugular Intrahepatic Portosystemic Shunt on patients' risk of death [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• Age between 18 and 80 years old;
• Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);
• The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);
• Patients with indications for Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment of cirrhotic portal hypertension, such as those with cirrhotic portal hypertension-related esophagogastric variceal bleeding refractory to endoscopic treatment, and patients with refractory ascites caused by cirrhotic portal hypertension;
• Obtained informed consent signed by the patient or their family members.

Exclusion criteria

• Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);
• TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);
• Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;
• Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score > 18;
• Pregnant patients;
• Patients with uncontrolled systemic infection or inflammation;
• Patients with severe coagulation disorders;
• Patients allergic to contrast medium.

Criteria for Termination/Withdrawal from the Study:

• Patients with Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure failure due to various reasons;
• Patients who voluntarily request to withdraw from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 15 centers

• Second Xiangya Hospital, Central South University — Changsha
• The Third Xiangya Hospital of Central South University — Changsha
• Fujian Medical University Union Hospital — Fuzhou
• Huanggang Central Hospital — Huanggang
• Jingzhou Central Hospital — Jingzhou
• Jiangxi Provincial People's Hospital — Nanchang
• The First Affiliated Hospital of Nanjing Medical University — Nanjing
• Shengjing Hospital of China Medical University — Shenyang
• … and 7 more centers

Identifiers

NCT: NCT07172035 · TIPS-Recompensation

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗