The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis

NCT ID: NCT07172035

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-08-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years old;

2. Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);

3. The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);

4. 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;

5. Obtained informed consent signed by the patient or their family members.

Exclusion Criteria

1. Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);

2. TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);

3. Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;

4. Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score > 18;

5. Pregnant patients;

6. Patients with uncontrolled systemic infection or inflammation;

7. Patients with severe coagulation disorders;

8. Patients allergic to contrast medium.

Criteria for Termination/Withdrawal from the Study:

1. Patients with Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure failure due to various reasons;

2. Patients who voluntarily request to withdraw from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

Yichang Central People's Hospital

OTHER

Sponsor Role: collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role: collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Provincial People's Hopital

OTHER

Sponsor Role: collaborator

The Central Hospital of Huanggang

OTHER

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Yaowei Bai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Xiangya Hospital, Central South University

Changsha, , China

Site Status: RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, , China

Site Status: RECRUITING

Fujian Medical University Union Hospital

Fuzhou, , China

Site Status: RECRUITING

Huanggang Central Hospital

Huanggang, , China

Site Status: RECRUITING

Jingzhou Central Hospital

Jingzhou, , China

Site Status: RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, , China

Site Status: RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status: RECRUITING

Shengjing Hospital of China Medical University

Shenyang, , China

Site Status: RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, , China

Site Status: RECRUITING

Renmin Hospital of Wuhan University

Wuhan, , China

Site Status: RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status: RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, , China

Site Status: RECRUITING

Xiangyang Central Hospital

Xiangyang, , China

Site Status: RECRUITING

Yichang Central People's Hospital

Yichang, , China

Site Status: RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yaowei Bai

Role: CONTACT

baiyaowei918@163.com

+8618627162379

Other Identifiers

TIPS-Recompensation

Identifier Type: -

Identifier Source: org_study_id