An interventional study of Proximal Splenic Artery Embolization in Ascites, Liver Cirrhosis and Hypertension, Portal, sponsored by Massachusetts General Hospital. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 179 interventional studies indexed under Ascites.
Browse Ascites studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Change in Ascites-Q Total Score
Change in Ascites-Q Total Score, a validated 11-item ascites-specific symptom questionnaire, reported on 0-100 scale where higher score indicates greater ascites-related symptom burden
Time frame: Baseline to Months 1,3, and 6
Change in Ascites-Q Subscale Scores
Change in individual Ascites-Q item-level scores across 11 symptom domains (including abdominal fullness, early satiety, dyspnea, and reduced mobility), each rated from 0 to 5, with higher scores indicating greater symptom burden
Time frame: Baseline to Months 1,3, and 6
Change in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Domain Scores
Change in PROMIS-29 Profile version 2.0 T-scores across seven domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference) and the single-item pain intensity score. T-scores have a mean of 50, and Standard deviation of 10; higher scores indicate more of the domain being measured (example: a higher Physical Education score indicates better function, while a higher anxiety score indicates more anxiety)
Time frame: Baseline to Months 1,3, and 6
Change in Liver Frailty Index
Change in Liver Frailty Index, a composite score derived from grip strength, time chair stands, and balance testing. Scores below 3.2 indicate robust status, 3.2 to below 4.5 indicate prefail status, and 4.5 or higher indicate frail status
Time frame: Baseline to Months 1,3, and 6
Change in L3 Skeletal Muscle Index
Change in skeletal muscle index measured at the L3 vertebral level by non-contrast CT
Time frame: Baseline to Month 6
Change in Skeletal Muscle Quality
Change in mean skeletal muscle attenuation, measured in Hounsfield units at the L3 vertebral level by non-contrast CT
Time frame: Baseline to Month 6
Change in Subcutaneous Fat Area
Change in subcutaneous adipose tissue area measured at the L3 Vertebral level by non-contrast CT
Time frame: Baseline to Month 6
Change in Visceral Fat Area
Change in Visceral adipose tissue area measured at the L3 vertebral level by non-contrast CT
Time frame: Baseline to Month 6
Change in Intermuscular Adipose Tissue Area
Change in intermuscular adipose tissue area measured at the L3 vertebral level by non-contrast CT
Time frame: Baseline to Month 6
Change in Splenic Volume
Change in splenic volume measured by CT
Time frame: Baseline to Month 6
Change in Spleen-to-Liver Volume Ratio
Change in the ratio of splenic volume to liver volume measured by CT
Time frame: Baseline to Month 6
Incidence of Splenic Infarction on Month-6 CT
Number of participants with splenic infarction identified on Month-6 CT
Time frame: At Month 6
Extent of Splenic Infarction on Month-6 CT
Extent of splenic infarction, expressed as the percentage of splenic parenchyma involved, on Month-6 CT imaging
Time frame: At Month 6
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
Data sharing details ↗ · repository.niddk.nih.gov
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2030, 42 months later.
Of 33 interventional studies with no phase under Ascites, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's planned 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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