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

Официальное название

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

Обзор

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.

Первичные конечные точки

• 1-year post-TIPS recompensation rate [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Identification of factors associated with recompensation at 1 year after TIPS [Срок оценки: 1 year]
• Impact of recompensation on the risk of hepatocellular carcinoma (HCC) development [Срок оценки: 1 year]
• Impact of recompensation after Transjugular Intrahepatic Portosystemic Shunt on patients' risk of death [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 15 центров

• Second Xiangya Hospital, Central South University — Чанша
• The Third Xiangya Hospital of Central South University — Чанша
• Fujian Medical University Union Hospital — Фучжоу
• Huanggang Central Hospital — Huanggang
• Jingzhou Central Hospital — Jingzhou
• Jiangxi Provincial People's Hospital — Nanchang
• The First Affiliated Hospital of Nanjing Medical University — Нанкин
• Shengjing Hospital of China Medical University — Шэньян
• … и ещё 7 центров

Идентификаторы

NCT: NCT07172035 · TIPS-Recompensation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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