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

NCT07172035 | Recruiting DMC

• 1 other identifier: TIPS-Recompensation
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 15

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

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

Keywords

Cirrhosis; decompensation; transjugular intrahepatic portosystemic shunt (TIPS); Survival analysis

Outcome Measures

Primary Outcomes (1)

• 1-year post-TIPS recompensation rate

  It refers to the proportion of patients who meet the standardized recompensation criteria (etiology cure, resolution of decompensation events and sustained improvement of liver function) at 12 months after TIPS.

  1 year

Secondary Outcomes (3)

• Identification of factors associated with recompensation at 1 year after TIPS

  1 year

• Impact of recompensation on the risk of hepatocellular carcinoma (HCC) development

  1 year

• Impact of recompensation after Transjugular Intrahepatic Portosystemic Shunt on patients' risk of death

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population of this research consists of patients with decompensated cirrhotic portal hypertension who meet the predefined inclusion and exclusion criteria and undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.

You may qualify if:

• Age between 18 and 80 years old;
• Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);
• The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);
• 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;
• Obtained informed consent signed by the patient or their family members.

You may not qualify if:

• Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);
• TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);
• Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;
• Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score \> 18;
• Pregnant patients;
• Patients with uncontrolled systemic infection or inflammation;
• Patients with severe coagulation disorders;
• Patients allergic to contrast medium.
• Criteria for Termination/Withdrawal from the Study:
• Patients with Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure failure due to various reasons;
• Patients who voluntarily request to withdraw from the study.

Sponsors & Collaborators

• Zhongnan Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Jiangxi Provincial People's Hopital: collaborator
• The Central Hospital of Huanggang: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Shengjing Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shanxi Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (15)

Second Xiangya Hospital, Central South University

Changsha, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, China

RECRUITING

Huanggang Central Hospital

Huanggang, China

RECRUITING

Jingzhou Central Hospital

Jingzhou, China

RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, China

RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, China

RECRUITING

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

Wuhan, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, China

RECRUITING

Yichang Central People's Hospital

Yichang, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yaowei Bai

CONTACT

+8618627162379; baiyaowei918@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (15)