Proximal Splenic Artery Embolization for Ascites

Not yet recruiting at 2 trial locations
EP
PR
Overseen ByPooja Ramakrishnan, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

EP

Eric P. Wehrenberg-Klee, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Life expectancy ≥ 6 months as judged by investigator
Able and willing to provide written informed consent and adhere to study schedule
Abdominal CT or MRI within 60 days confirming patency of main portal and splenic veins and absence of contraindications to PSAE
See 6 more

Exclusion Criteria

I am under 18 years old.
I do not have any active or uncontrolled serious infections.
I have had recent stomach or intestinal bleeding or untreated high-risk varices.
See 13 more

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Proximal Splenic Artery EmbolizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+