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

NCT07755059 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 2026P0017751R01DK144165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Ascites; Liver Cirrhosis; Hypertension, Portal

Keywords

Refractory Ascites; Decompensated Cirrhosis; Proximal Splenic Artery Embolization; Splenic Artery Embolization; Large Volume Paracentesis; Trans Jugular Intrahepatic Portosystemic Shunt; Hepatic Venous Pressure Gradient

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  Within 6 months of PSAE

Secondary Outcomes (19)

• Change in Hepatic Venous Pressure Gradient at Month 1

  Day 0 (pre-embolization) to Month 1 post PSAE

• Change in Hepatic Artery Resistive Index (RI)

  Baseline to Month 1 post-PSAE

• Change in Daily Diuretic Dose

  Baseline to Month 6 post-PSAE

• Time to Resolution of Large-Volume Paracentesis Dependence

  From PSAE up to Month 6

• Acute Change in HPVG

  Day 0 (pre-procedure to immediately post-procedure)

Other Outcomes (13)

• Change in Ascites-Q Total Score

  Baseline to Months 1,3, and 6

• Change in Ascites-Q Subscale Scores

  Baseline to Months 1,3, and 6

• Change in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Domain Scores

  Baseline to Months 1,3, and 6

Study Arms (1)

Proximal Splenic Artery Embolization

EXPERIMENTAL

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.

Device: Proximal Splenic Artery Embolization

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.

Also known as: coil embolization, plug embolization

Proximal Splenic Artery Embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of informed consent.
• Decompensated cirrhosis confirmed by clinical, laboratory, radiographic, or histologic criteria.
• Portal hypertension of sinusoidal origin. Pre-sinusoidal (e.g., idiopathic non-cirrhotic portal hypertension, schistosomiasis) and post-sinusoidal (e.g., Budd-Chiari syndrome, right-heart failure, constrictive pericarditis) etiologies are excluded.
• Refractory or recurrent ascites defined as ascites not controlled by maximum tolerated diuretic therapy (spironolactone ≤ 400 mg/day + furosemide ≤ 160 mg/day, or maximum tolerated doses below these limits) and sodium restriction, or diuretic-intractable due to diuretic-induced complications.
• Demonstrated large-volume paracentesis (LVP) dependence for ≥ 3 consecutive months prior to screening, with ≥ 2 LVP sessions per month on average during that window, documented in the institutional medical record or in external paracentesis procedure records released to the investigator.
• Ineligible or relatively contraindicated for TIPS. Acceptable reasons include but are not limited to: MELD-Na \> 18 with additional risk factors, pre-existing or recurrent overt hepatic encephalopathy, advanced age with comorbidity, clinically significant cardiopulmonary disease, or anatomic contraindication.
• Life expectancy ≥ 6 months in the judgment of the enrolling investigator.
• Able and willing to provide written informed consent and to adhere to the study visit and assessment schedule.
• Abdominal cross-sectional imaging (CT or MRI) within 60 days of enrollment confirming patency of the main portal vein and main splenic vein, and absence of findings that would contraindicate PSAE.

You may not qualify if:

• Age \< 18 years.
• Unable to provide informed consent and without an appropriate legally authorized representative.
• Pre-sinusoidal or post-sinusoidal portal hypertension (e.g., extrahepatic portal vein thrombosis, idiopathic non-cirrhotic portal hypertension, schistosomiasis, Budd-Chiari syndrome, hepatic sinusoidal obstruction syndrome, constrictive pericarditis, right-heart failure).
• Main portal vein thrombosis, splenic vein thrombosis, or superior mesenteric vein thrombosis on screening imaging.
• Active listing for liver transplantation with MELD-Na ≥ 20 at screening, or any listing status in which transplantation within 6 months is judged highly likely by the site transplant team. (Listed participants with MELD-Na \< 20 and low anticipated short-term transplant probability may be enrolled with documented site transplant-team concurrence.)
• Pre-existing splenectomy, prior distal splenic artery embolization, or pre-existing splenic abscess, large splenic infarction (≥ 30% of splenic parenchyma), or splenic mass on imaging.
• Active or uncontrolled systemic infection, including spontaneous bacterial peritonitis in the prior 14 days, bacteremia in the prior 14 days, or any infection requiring parenteral antibiotics at the time of screening.
• Active gastrointestinal bleeding within 14 days, or untreated high-risk esophageal or gastric varices (primary prophylaxis not yet established) - treatable prior to enrollment.
• Severe coagulopathy not correctable to INR ≤ 2.0 and platelets ≥ 30 × 10⁹/L on the day of the procedure.
• Known severe allergy to iodinated contrast not manageable with standard pre-medication, or contrast contraindication precluding cross-sectional CT imaging.
• eGFR \< 30 mL/min/1.73 m² not on renal replacement therapy, unless iodinated contrast use can be minimized per site protocol and nephrology concurrence is documented.
• Pregnancy or breastfeeding. Participants of childbearing potential must have a negative serum pregnancy test at screening and agree to effective contraception through Month 6.
• Hepatocellular carcinoma beyond BCLC Stage A, or any active extrahepatic malignancy with life expectancy \< 6 months.
• Enrollment in another interventional clinical trial within 30 days or concurrent with this study that could confound endpoints, including TIPS-related trials.
• Any medical, psychiatric, or social condition that in the investigator's judgment would preclude safe participation or adherence to the protocol.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ascites; Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis

Study Officials

• Eric P. Wehrenberg-Klee, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric P. Wehrenberg-Klee, MD

CONTACT

6176430034; ewehrenberg-klee@mgb.org

Pooja Ramakrishnan, MS

CONTACT

6177246819; pramakrishnan2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Radiologist

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified IPD and supporting documents will be made available beginning 12 months after publication of the trial's primary results manuscript, or no later than the date required by the NIH Data Management and Sharing Policy and NIDDK Central Repository submission timelines, whichever is earlier. Data will remain available for a minimum of 10 years after initial release. The study protocol, statistical analysis plan, blank informed consent form, and de-identified data dictionary will be submitted to the NIDDK Central Repository at the time of primary results publication. Analytic code used to generate published results will be deposited concurrently with each publication.
• Access Criteria: IPD and supporting materials will be deposited in and distributed through the NIDDK Central Repository (NIDDK-CR). Requests will be handled per NIDDK-CR standard procedures. Qualified investigators must submit: (1) a research proposal describing scientific aims, hypotheses, methods, and analytic plan; (2) evidence of IRB/ethics review or exemption at the requester's institution; and (3) an executed Data Use Agreement prohibiting re-identification, restricting use to the approved analysis, and requiring appropriate acknowledgment. Requests will be reviewed by the NIDDK-CR in consultation with the Trial Steering Committee, which will evaluate scientific merit, methodologic soundness, feasibility with the available data, and absence of conflict with pre-specified secondary analyses by the study team during a defined exclusivity period after primary publication. Approved requesters will receive de-identified IPD via a secure transfer mechanism.

Locations

US (3)