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

Status: Recruiting
Location: See all (15) locations...
Study Type: Observational
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 highly likely to develop further decompensation events or even death \[1-2\]. 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 \[3\]. 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 \[4\]. In patients with hepatitis B-related cirrhosis, 6% achieved recompensation after treatment with nucleos(t)ide analogs, with a similar improvement in mortality \[5\]. 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 \[6-7\]. Compared with standard treatment, TIPS has been proven to reduce the incidence of further decompensation and improve transplant-free survival \[8-9\]. However, due to portal blood shunting, the risks of abnormal liver function and hepatic encephalopathy (HE) also increase \[10\]. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old;

• Diagnosed with decompensated cirrhosis (Diagnostic criteria: positive liver histology, or comprehensive assessment based on clinical symptoms, biochemical indicators, and imaging features);

• Intervenable aetiology (HBV/HCV/alcohol/MASLD).

Locations
Other Locations
China
Second Xiangya Hospital, Central South University
RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Huanggang Central Hospital
RECRUITING
Huanggang
Jingzhou Central Hospital
RECRUITING
Jingzhou
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Provincial People's Hospital
RECRUITING
Taiyuan
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
Yichang Central People's Hospital
RECRUITING
Yichang
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yaowei Bai
baiyaowei918@163.com
+8618627162379
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 233
Treatments
Recompensation group
Refers to the group of patients who simultaneously meet the three core criteria of etiology cure, resolution of decompensation events and sustained improvement of liver function at 1 year after TIPS creation
Non-Recompensation Group
Refers to the group of patients who fail to meet the three core criteria of etiology cure, resolution of decompensation events and sustained improvement of liver function at 1 year after TIPS creation.
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: The Central Hospital of Huanggang, Jiangxi Provincial People's Hopital, Jingzhou Central Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital with Nanjing Medical University, Second Xiangya Hospital of Central South University, Shengjing Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Fujian Medical University Union Hospital, Renmin Hospital of Wuhan University, Zhongnan Hospital, Xiangyang Central Hospital, Yichang Central People's Hospital

This content was sourced from clinicaltrials.gov

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