Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT07172035
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Recompensation in Patients With Decompensated Cirrhosis: A Multicenter Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: