Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy
United States34 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answer are:
1. Does EUS guided embolization maintain an acceptable safety profile?
2. Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?
Participants will:
1. Receive EUS guided embolization or medical management.
2. Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).
3. Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged ≥18 years with known cirrhosis
. MRHE; defined as ≥2 episodes of hepatic encephalopathy, HE (as documented in an outpatient office visit or during an inpatient admission) within 6 months prior to enrollment despite medical therapy with lactulose and rifaximin
. Admission to inpatient hepatology floor at University Hospital-Newark with MRHE at the time of enrollment
. Presence of a spontaneous portosystemic shunt; confirmed on CT/MRI at the index admission.
Exclusion criteria
. Severe/refractory ascites defined as ascites that does not recede after medical therapy or reoccurs shortly after fluid has been removed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The severity of hepatic encephalopathy
Timeframe: 4 weeks after intervention
Trial details
NCT IDNCT07553858
SponsorRutgers, The State University of New Jersey