How TIPS affects liver recompensation in people with decompensated cirrhosis

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

This observational project will see if placing a transjugular intrahepatic portosystemic shunt (TIPS) helps adults (18–80) with decompensated cirrhosis from treatable causes to achieve liver recompensation and improve survival.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 15 sites (Changsha and 14 other locations)
• Trial ID: NCT07172035 on ClinicalTrials.gov

What this trial studies

This is a multicenter observational cohort of adults with decompensated cirrhosis who meet indications for TIPS (for example, refractory variceal bleeding or refractory ascites) and have intervenable etiologies such as HBV, HCV, or alcohol. Patients who undergo TIPS will be followed over time for clinical signs of liver recompensation using the Baveno VII criteria and for survival outcomes. The study will use survival analysis methods to compare rates and timing of recompensation and liver-related mortality. Data will be collected across several major Chinese hospitals to capture real-world outcomes after TIPS placement.

Who should consider this trial

Good fit: Adults 18–80 with decompensated liver cirrhosis from intervenable causes who have indications for TIPS (such as refractory variceal bleeding or refractory ascites) and can provide informed consent are the ideal candidates.

Not a fit: Patients with compensated cirrhosis, irreversible end-stage liver disease, non-intervenable causes, or clear contraindications to TIPS (for example severe uncontrolled hepatic encephalopathy) are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, TIPS could increase the chance of liver recompensation and lower liver-related deaths in selected patients with decompensated cirrhosis.

How similar studies have performed: Previous cohort data show that etiologic treatments (like alcohol cessation or antiviral therapy) can lead to recompensation in some patients, and while TIPS is established for portal-hypertension control, its specific role in promoting liver recompensation remains relatively novel and not well proven.

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.

Where this trial is running

Changsha and 14 other locations

• 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)

Study contacts

• Study coordinator: Yaowei Bai

Conditions Cirrhosis; Decompensation; Transjugular Intrahepatic Portosystemic Shunt; Survival Analysis; decompensation; transjugular intrahepatic portosystemic shunt; Survival analysis