Actively Recruiting
The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-05
250
Participants Needed
15
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
Z
Zhongnan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosed with decompensated liver cirrhosis by liver biopsy or clinical, biochemical, and imaging features
- Liver cirrhosis caused by treatable conditions such as hepatitis B, hepatitis C, or alcoholic liver disease
- Indications for TIPS treatment including refractory esophagogastric variceal bleeding or refractory ascites due to cirrhotic portal hypertension
- Signed informed consent by the patient or their family members
You will not qualify if you...
- Compensated liver cirrhosis without decompensated events like ascites, hepatic encephalopathy, or bleeding at TIPS treatment
- TIPS performed for non-cirrhotic portal hypertension such as idiopathic portal hypertension, Budd-Chiari syndrome, or sinusoidal obstruction syndrome
- Presence of malignant tumors like hepatocellular carcinoma, renal cell carcinoma, or lung cancer before TIPS
- Severe cardiopulmonary dysfunction or MELD score greater than 18
- Pregnancy
- Uncontrolled systemic infection or inflammation
- Severe coagulation disorders
- Allergy to contrast medium
- TIPS procedure failure
- Voluntary withdrawal from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Second Xiangya Hospital, Central South University
Changsha, China
Actively Recruiting
2
The Third Xiangya Hospital of Central South University
Changsha, China
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3
Fujian Medical University Union Hospital
Fuzhou, China
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4
Huanggang Central Hospital
Huanggang, China
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5
Jingzhou Central Hospital
Jingzhou, China
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6
Jiangxi Provincial People's Hospital
Nanchang, China
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7
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
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8
Shengjing Hospital of China Medical University
Shenyang, China
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9
Shanxi Provincial People's Hospital
Taiyuan, China
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10
Renmin Hospital of Wuhan University
Wuhan, China
Actively Recruiting
11
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
12
Zhongnan Hospital of Wuhan University
Wuhan, China
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13
Xiangyang Central Hospital
Xiangyang, China
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14
Yichang Central People's Hospital
Yichang, China
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15
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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Research Team
Y
Yaowei Bai
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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