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
Study ID
NCT07172035
Status
Recruiting
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Conditions

  • Cirrhosis
  • Decompensation
  • Survival Analysis
  • Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 15, 2025
Start date
Aug 1, 2025
Status verified
Nov 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.

Primary Outcome Measure

1-year post-TIPS recompensation rate [ Time Frame: 1 year ]

Central Contacts

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