Status:
RECRUITING
The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Zhongnan Hospital
Yichang Central People's Hospital
Conditions:
Cirrhosis
Decompensation
Eligibility:
All Genders
18-80 years
Brief Summary
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 hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07172035
Start Date
August 1 2025
End Date
August 1 2027
Last Update
December 5 2025
Active Locations (15)
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1
Second Xiangya Hospital, Central South University
Changsha, China
2
The Third Xiangya Hospital of Central South University
Changsha, China
3
Fujian Medical University Union Hospital
Fuzhou, China
4
Huanggang Central Hospital
Huanggang, China