Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07755059
Status
Not Yet Recruiting

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Conditions

  • Ascites
  • Hypertension, Portal
  • Liver Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proximal Splenic Artery Embolization — DEVICE
    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.

Study Details

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

Key Dates

First listed
Aug 10, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Apr 1, 2030
Completion
Oct 1, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proximal Splenic Artery Embolization
    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.

Primary Outcome Measure

Change in Monthly Frequency of Large-Volume Paracentesis Sessions [ Time Frame: Baseline (3-month period ending on day of PSAE) to Month 6 post-PSAE ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Vijay Ramalingam, MD
[email protected]
Nathan Yoguez
[email protected]
Vijay Ramalingam (PRINCIPAL_INVESTIGATOR)
Brigham & Women's HospitalBostonMassachusetts02115
Alex Jacobson, MD
[email protected]
6177751741
Alex Jacobson, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Eric P. Wehrenberg-Klee, MD
[email protected]
6176430034
Pooja Ramakrishnan, MS
[email protected]
6177246819
Eric P. Wehrenberg-Klee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham & Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MA

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