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

A Prospective, Multi-Center, Single-Arm Clinical Study of Proximal Splenic Artery Embolization (PSAE) for the Treatment of Refractory Ascites in Decompensated Cirrhosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Secondary endpoints include change in HVPG, hepatic artery resistive index by Doppler ultrasound, diuretic dose, and time to resolution of paracentesis dependence."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PSAE, a procedure that slows blood flow to the spleen, can reduce the need to drain fluid from the belly. It is for adults with severe liver scarring (cirrhosis) whose fluid buildup is not controlled by water pills and diet, and for whom a standard procedure called TIPS is not a safe option.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have confirmed cirrhosis that is causing serious health problems.
  • Have high pressure in the veins leading to the liver caused by changes in the liver’s tiny blood vessels.
  • Have belly fluid that water pills and a low-salt diet cannot control, or be unable to take enough water pills because of side effects.
  • Have records showing large amounts of belly fluid were drained at least twice a month on average for at least 3 months in a row.
  • Be unable to have TIPS, a procedure that creates a new path for blood through the liver, or have risks that make it unsafe.
  • Be expected by the study doctor to live at least 6 months.
  • Be able and willing to give written consent and follow the study visit and test schedule.
  • Have a CT or MRI scan within 60 days before joining that shows the main liver and spleen veins are open and no findings that make PSAE unsafe.

Who can't join

  • Be under 18, or be unable to give consent without a suitable legal representative. Other health, mental health, or social problems that prevent safe participation or following study steps also rule you out.
  • Have high liver-vein pressure from a cause outside the liver’s tiny blood vessels, or blood clots in the main liver vein, spleen vein, or main vein draining the intestines.
  • Be on the liver transplant list with a MELD-Na liver disease score of 20 or higher, or be very likely to receive a transplant within 6 months. Have liver cancer beyond BCLC stage A, or active cancer outside the liver with expected survival under 6 months.
  • Have had the spleen removed or a prior procedure blocking smaller spleen arteries. Have a pocket of infection, a mass, or dead tissue affecting at least 30% of the spleen.
  • Have an active or uncontrolled body-wide infection, a belly-fluid or bloodstream infection in the past 14 days, or need antibiotics by injection. Have bleeding in the digestive tract within 14 days or untreated swollen veins in the food pipe or stomach that could bleed.
  • Have blood-clotting problems that cannot be corrected enough for the procedure, a severe scan-dye allergy that medicines cannot manage, or another reason CT dye cannot be used. Very poor kidney function may also rule you out unless the study’s exceptions are met.
  • Be pregnant or breastfeeding. People who could become pregnant must have a negative blood pregnancy test and use effective birth control through month 6.
  • Have a drug use disorder, other than alcohol or tobacco use, that would prevent following study steps. Be in another treatment trial within 30 days or at the same time that could affect this study’s results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Study sites (3)

MA