A Prospective, Multi-Center, Single-Arm Clinical Study of Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis

Summary

The purpose of this study is to learn whether a procedure called Proximal Splenic Artery Embolization (PSAE) can lower the need for repeat fluid drainage in adults with cirrhosis and a buildup of fluid in the abdomen (ascites) that is no longer controlled by water pills and diet. Participants in this study have already been told that a standard procedure called Trans jugular Intrahepatic Portosystemic Shunt (TIPS) is not a safe option for them. The main objectives this study aims to answer are: * Does PSAE lower how often participants need paracentesis, the procedure used to drain fluid from the abdomen? * Does PSAE lower the total amount of fluid drained each month? * Does PSAE change the pressure inside the liver's veins and the blood flow in the liver and spleen? * Does PSAE improve day-to-day symptoms, quality of life, strength, and the ability to do usual activities? * What side effects or complications happen with PSAE in this group of people? Participants will: * Undergo one PSAE procedure, during which small coils and/or plugs are placed in the artery that supplies the spleen to slow its blood flow * Have a pressure measurement taken in the liver's veins right before and right after the procedure, with a repeat measurement at 1 month * Attend follow-up visits at 1, 3, and 6 months that include blood tests, ultrasounds, symptoms and quality-of-life questionnaires, and a review of any paracentesis sessions since the last visit * Have a Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) and an ultrasound of the liver and spleen blood vessels at the start of the study and again at 6 months

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