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Proximal Splenic Artery Embolization for Treatment of Refractory Ascites in Decompensated Cirrhosis

Award Number: R01DK144165
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Proximal Splenic Artery Embolization for Treatment of Refractory Ascites in Decompensated Cirrhosis - Project Summary/Abstract Refractory ascites is a major cause of morbidity for patients with decompensated cirrhosis. For some patients creation of a transjugular intrahepatic portosystemic shunt (TIPS) is a therapeutic option to relieve ascitic burden. This procedure, while beneficial to many patients, carries a meaningful risk of hepatic encephalopathy and liver failure. Many patients with refractory ascites are deemed too high risk for TIPS due to the risk of hepatic decompensation or hepatic encephalopathy or are relatively contraindicated due to comorbidities. These patients' ascites is managed with repeat, often weekly large volume paracentesis (LVP). LVP is a low-risk procedure, but provides very unsatisfactory ascites control and these patients have a poor quality of life as a result. For patients who are LVP- dependent an improved method of ascites control is urgently needed. Proximal splenic artery-embolization (PSAE) is a percutaneous procedure that may provide symptom relief for these patients but has received little clinical investigation to date. In PSAE the proximal aspect of the splenic artery is blocked with coils or vascular plugs, significantly decreasing arterial supply to the spleen. Some blood flow to the spleen is maintained through multiple anatomic collateral vascular pathways. Decreased splenic arterial inflow means less splenic venous outflow. With reduced blood flow, portal pressure is reduced, which in turn leads to decreased ascites. We have shown in a retrospective study evaluating our institutional experience that PSAE led to complete resolution of ascites in 7 out of 10 patients and patients experienced no procedure-related adverse events. This study suggests tremendous potential for PSAE as an additional treatment option for patients ineligible for TIPS, but much more clinical information regarding the procedure needs to be obtained to better understand its risks and benefits as well as appropriate patient selection. To advance clinical knowledge of PSAE for the treatment of refractory ascites we will conduct a multi-center prospective clinical trial in 50 patients evaluating the efficacy and safety of PSAE. The aims of our clinical trial will be to 1) evaluate the ability of PSAE to treat ascites and the degree of portal pressure reduction it causes, 2) assess the adverse event profile associated with PSAE in this population, and 3) determine the impact on patient reported quality of life metrics as well as impact on functional status using validated metrics.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $660,048 )
2026	2026	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/16/2026	NEW	$660,048
														Subtotal = $660,048

Grand Total All Awards = $660,048

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Proximal Splenic Artery Embolization for Treatment of Refractory Ascites in Decompensated Cirrhosis

Award Number: R01DK144165

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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