Proximal Splenic Artery Embolization for Ascites
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Eric P. Wehrenberg-Klee, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All enrolled participants undergo a single PSAE procedure. Small embolization coils and/or vascular plugs are placed in the proximal splenic artery to reduce arterial blood flow to the spleen while preserving splenic viability through collateral vessels. HVPG is measured immediately before and after embolization. Oral antibiotic prophylaxis is given for 7 days following the procedure. Participants are followed for 6 months after PSAE, during which paracentesis records, laboratory data, imaging, and patient-reported outcomes are collected.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.