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
Refractory ascites is a common complication of decompensated cirrhosis and carries a substantial symptom burden and reduced quality of life. Standard management includes repeated large-volume paracentesis and, for eligible candidates, placement of TIPS. TIPS is effective for many patients but carries a meaningful risk of hepatic decompensation, new or worsening hepatic encephalopathy and is not a safe option for patients with a high Model for End-Stage Liver Disease (MELD) score, prior encephalopathy, cardiac dysfunction, or unfavorable vascular anatomy. PSAE is a catheter-based procedure in which 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. By lowering splenic blood flow into the portal venous system, PSAE is expected to reduce portal pressure and the driving force behind ascites formation, without creating a new vascular connection that could trigger hepatic encephalopathy. This is a prospective, multi-center, single-arm, open-label study. Eligible participants undergo a single PSAE procedure, with Hepatic Venous Pressure Gradient (HVPG) measurement performed immediately before and after embolization, followed by 6 months of structured follow-up including laboratory testing, imaging, and patient-reported assessments. An independent Data Safety Monitoring Board (DSMB) reviews safety data at pre-specified intervals throughout the study. The co-primary effectiveness endpoints are the change from baseline to Month 6 in the average monthly number of large-volume paracentesis sessions and the change in the average monthly volume of ascitic fluid drained. The primary safety endpoint is the proportion of participants who experience a major procedure-related adverse event within 6 months of PSAE. Secondary endpoints include change in HVPG, hepatic artery resistive index by Doppler ultrasound, diuretic dose, and time to resolution of paracentesis dependence. Additional assessments capture patient-reported symptom burden and quality of life, physical frailty, hepatic encephalopathy grading, laboratory measures of liver and kidney function, and body composition by CT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
A one-time transcatheter arterial procedure performed under moderate sedation or monitored anesthesia care. Common femoral arterial access is obtained under ultrasound guidance, and a catheter is advanced into the splenic artery. Embolic coils and/or vascular plugs, cleared for peripheral vascular embolization, are deployed to achieve angiographic cessation of antegrade flow in the proximal splenic artery, while collateral flow to the spleen is preserved. Oral antibiotic prophylaxis is given for 7 days following the procedure.
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Change in Monthly Frequency of Large-Volume Paracentesis Sessions
Change from the mean monthly number of large-volume paracentesis (LVP) sessions during the 3-month period before PSAE to the number of sessions in the 28-day window ending at the Month 6 visit, abstracted from clinical and procedural records.
Time frame: Baseline (3-month period ending on day of PSAE) to Month 6 post-PSAE
Change in Monthly Volume of Ascites Fluid Drained
Change from the mean monthly total volume (in liters) of ascites fluid drained during the 3-month period before PSAE to the total volume drained in the 28-day window ending at the Month-6 visit, abstracted from clinical and procedural records
Time frame: Baseline (3-month period ending on day of PSAE) to Month 6 post-PSAE
Proportion of Participants with a Major Procedure-Related Adverse Event
Proportion of participants experiencing at least one procedure-related adverse event graded Society of Interventional Radiology (SIR) Adverse Event Classification System (2017) grade 3 or higher, cross-referenced to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 grading
Time frame: Within 6 months of PSAE
Change in Hepatic Venous Pressure Gradient at Month 1
Change in HVPG, measured in mmHg by trans jugular catheterization and calculated as wedged hepatic venous pressure minus free hepatic venous pressure, from the pre-embolization measurement on the day of PSAE to the Month-1 follow-up measurement
Time frame: Day 0 (pre-embolization) to Month 1 post PSAE
Change in Hepatic Artery Resistive Index (RI)
Change in hepatic artery resistive index, measured by Doppler ultrasound and calculated as (difference between peak systolic velocity and end-diastolic velocity) divided by peak systolic velocity
Time frame: Baseline to Month 1 post-PSAE
Change in Daily Diuretic Dose
Change in daily diuretic dose, expressed in spironolactone-equivalent and furosemide-equivalent units
Time frame: Baseline to Month 6 post-PSAE
Time to Resolution of Large-Volume Paracentesis Dependence
Time from PSAE to the first 60-day interval without a large-volume paracentesis session, analyzed with death and liver transplantation treated as competing events
Time frame: From PSAE up to Month 6
Acute Change in HPVG
Change in HPVG, measured in mmHg, from immediately before to immediately after the PSAE procedure
Time frame: Day 0 (pre-procedure to immediately post-procedure)
Change in Portal-Venous Flow Velocity
Change in main portal vein blood flow velocity, measured by Doppler ultrasound
Time frame: Baseline to Month 1
Change in Splenic-Venous Flow Velocity
Change in splenic venous flow velocity, measured by Doppler ultrasound
Time frame: Baseline to Month 1
Rate of Unplanned Hospital admissions and Emergency Department visits related to Portal Hypertension Complications
Rate and cumulative incidence of unplanned hospital admissions and emergency department visits attributed to spontaneous bacterial peritonitis, hyponatremia, acute kidney injury, hepatic encephalopathy, or gastrointestinal variceal bleeding
Time frame: Over 6 months
Incidence of Hepatic Encephalopathy Episodes
Number of participants experiencing at least one hepatic encephalopathy episode
Time frame: Over 6 months
Severity of Hepatic Encephalopathy Episodes
Severity of hepatic encephalopathy episodes, graded using the West Haven criteria (Grade 0 to Grade 4, with higher grades indicating more severe encephalopathy)
Time frame: Over 6 months
Duration of Hepatic Encephalopathy Episodes
Duration, in days, of hepatic encephalopathy episodes
Time frame: Over 6 months
Change in Number Connection Test performance
Change in Number Connection Test score, a timed psychometric test for covert hepatic encephalopathy; longer compeltion time indicates worse performance
Time frame: Baseline to Months 1, 3, and 6
Change in Serum Creatinine
Change in Serum Creatinine level
Time frame: Baseline to Months 1, 3, and 6
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Time frame: Baseline to Months 1,3, and 6
Change in Model for End-Stage Liver Disease-Sodium (MELD-Na) Score
Change in Model for End-Stage Liver Disease-Sodium (MELD-Na) Score, calculated using the Organ Procurement and Transplantation Network (OPTN)-specified formula in effect at the time of enrollment
Time frame: Baseline to Months 1,3, and 6
Transplant-Free Survival
Time from PSAE to death, with liver transplantation treated as a competing event
Time frame: Over 6 Months
Proportion of Participants Achieving Large-Volume Paracentesis Independence
Proportion of participants who reach a 60-day interval without a large-volume paracentesis session, assessed at each visit
Time frame: At Months 1,3, and 6
Change in Child-Pugh Score
Change in Child-Pugh Score, calculated from total bilirubin, serum albumin, Internation Normalized Ratio (INR), degree of ascites, and degree of hepatic encephalopathy
Time frame: Baseline to Months 1,3, and 6
Change in Child-Pugh Class
Change in Child-Pugh Class (Class A, 5-6 points, Class B, 7-9 points; Class C, 10-15 points)
Time frame: Baseline to Months 1,3, and 6
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