How TIPS affects liver recompensation in people with decompensated cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Yaowei Bai
• Email: baiyaowei918@163.com
• Phone: +8618627162379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.