AscitesNCT07755059
Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis
A study testing Proximal Splenic Artery Embolization in people with Ascites and Liver Cirrhosis, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Liver Cirrhosis, Hypertension, Portal
- What is being tested?
- Proximal Splenic Artery Embolization
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Active substance use disorder other than alcohol or tobacco that, in the investigator's judgment, would preclude protocol adherence. Active alcohol use disorder is not exclusionary but is captured (AUDIT-C) and analyzed as a pre-specified covariate.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Eric P. Wehrenberg-Klee, MD, 6176430034, ewehrenberg-klee@mgb.org
Pooja Ramakrishnan, MS, 6177246819, pramakrishnan2@mgh.harvard.edu
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Alex Jacobson, MD, 6177751741, ajacobson3@mgb.org
Alex Jacobson, MD
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Vijay Ramalingam, MD, vramali1@bidmc.harvard.edu
Nathan Yoguez, nyoguez@bidmc.harvard.edu
About this study
Official title: A Prospective, Multi-Center, Single-Arm Clinical Study of Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis
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?
Read more
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
Read the detailed description
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.
- Conditions
- Ascites, Liver Cirrhosis, Hypertension, Portal
- Being tested
- Proximal Splenic Artery Embolization
- Keywords
- Refractory Ascites, Decompensated Cirrhosis, Proximal Splenic Artery Embolization, Splenic Artery Embolization, Large Volume Paracentesis, Trans Jugular Intrahepatic Portosystemic Shunt, Hepatic Venous Pressure Gradient
- Medical subject headings
- Ascites, Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Splenic Artery EmbolizationDevice
Also called coil embolization, plug embolization
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Proximal Splenic Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Within 6 months of PSAE
Secondary outcomes (19)
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
Measured: 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
Measured: Baseline to Month 1 post-PSAE
Change in Daily Diuretic Dose
Change in daily diuretic dose, expressed in spironolactone-equivalent and furosemide-equivalent units
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Month 1
Change in Splenic-Venous Flow Velocity
Change in splenic venous flow velocity, measured by Doppler ultrasound
Measured: 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
Measured: Over 6 months
Incidence of Hepatic Encephalopathy Episodes
Number of participants experiencing at least one hepatic encephalopathy episode
Measured: 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)
Measured: Over 6 months
Duration of Hepatic Encephalopathy Episodes
Duration, in days, of hepatic encephalopathy episodes
Measured: 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
Measured: Baseline to Months 1, 3, and 6
Change in Serum Creatinine
Change in Serum Creatinine level
Measured: 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
Measured: 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
Measured: Baseline to Months 1,3, and 6
Transplant-Free Survival
Time from PSAE to death, with liver transplantation treated as a competing event
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline to Months 1,3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Eric Wehrenberg-Klee, MD, Massachusetts General Hospital
- Investigators
- Eric P. Wehrenberg-Klee, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755059
- Sponsor's protocol ID
- 2026P001775
- Other IDs
- 1R01DK144165
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying all published results from this trial will be shared. The shared dataset will include baseline demographics and clinical characteristics; cirrhosis etiology and severity indices (MELD, MELD-Na, Child-Pugh); pre- and post-intervention paracentesis frequency and volumes; splenic and hepatic hemodynamic measurements; laboratory values including platelet counts, renal function, and liver function tests; imaging-derived measures (splenic volume, portal vein diameter); patient-reported outcome measures (ascites-specific quality of life); adverse events; and mortality/transplant/hospitalization outcomes through end of follow-up. Data will be released with a full data dictionary and codebook. Direct identifiers will be removed and dates shifted per HIPAA Safe Harbor.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Single-Arm Clinical Study of Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT07755059
- Acronym / sponsor ID
- 2026P001775
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal Splenic Artery Embolization | Experimental | Device: Proximal Splenic Artery EmbolizationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal Splenic Artery EmbolizationAlso: coil embolization, plug embolizationA 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. | Device | Proximal Splenic Artery Embolization |
Primary outcome
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
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.
Change in Monthly Volume of Ascites Fluid Drained
Time frame: Baseline (3-month period ending on day of PSAE) to Month 6 post-PSAE
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
Proportion of Participants with a Major Procedure-Related Adverse Event
Time frame: Within 6 months of PSAE
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
19 secondary outcomes
Change in Hepatic Venous Pressure Gradient at Month 1
Time frame: Day 0 (pre-embolization) to Month 1 post PSAE
Change in Hepatic Artery Resistive Index (RI)
Time frame: Baseline to Month 1 post-PSAE
Change in Daily Diuretic Dose
Time frame: Baseline to Month 6 post-PSAE
Time to Resolution of Large-Volume Paracentesis Dependence
Time frame: From PSAE up to Month 6
Acute Change in HPVG
Time frame: Day 0 (pre-procedure to immediately post-procedure)
Change in Portal-Venous Flow Velocity
Time frame: Baseline to Month 1
Change in Splenic-Venous Flow Velocity
Time frame: Baseline to Month 1
Rate of Unplanned Hospital admissions and Emergency Department visits related to Portal Hypertension Complications
Time frame: Over 6 months
Incidence of Hepatic Encephalopathy Episodes
Time frame: Over 6 months
Severity of Hepatic Encephalopathy Episodes
Time frame: Over 6 months
Duration of Hepatic Encephalopathy Episodes
Time frame: Over 6 months
Change in Number Connection Test performance
Time frame: Baseline to Months 1, 3, and 6
Change in Serum Creatinine
Time frame: Baseline to Months 1, 3, and 6
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline to Months 1,3, and 6
Change in Model for End-Stage Liver Disease-Sodium (MELD-Na) Score
Time frame: Baseline to Months 1,3, and 6
Transplant-Free Survival
Time frame: Over 6 Months
Proportion of Participants Achieving Large-Volume Paracentesis Independence
Time frame: At Months 1,3, and 6
Change in Child-Pugh Score
Time frame: Baseline to Months 1,3, and 6
Change in Child-Pugh Class
Time frame: Baseline to Months 1,3, and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying all published results from this trial will be shared. The shared dataset will include baseline demographics and clinical characteristics; cirrhosis etiology and severity indices (MELD, MELD-Na, Child-Pugh); pre- and post-intervention paracentesis frequency and volumes; splenic and hepatic hemodynamic measurements; laboratory values including platelet counts, renal function, and liver function tests; imaging-derived measures (splenic volume, portal vein diameter); patient-reported outcome measures (ascites-specific quality of life); adverse events; and mortality/transplant/hospitalization outcomes through end of follow-up. Data will be released with a full data dictionary and codebook. Direct identifiers will be removed and dates shifted per HIPAA Safe Harbor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric P. Wehrenberg-Klee, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Splenic Artery Embolization in people with Ascites and Liver Cirrhosis, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric P. Wehrenberg-Klee, MD (6176430034, ewehrenberg-klee@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.