Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial
Rutgers, The State University of New Jersey
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged ≥18 years with known cirrhosis 2. 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 3. Admission to inpatient hepatology floor at University Hospital-Newark with MRHE at the time of enrollment 4. Presence of a spontaneous portosystemic shunt; confirmed on CT/MRI at the index admission. Exclusion Criteria: 1. Severe/refractory ascites defined as ascites that does not recede after med…
Interventions
- ProcedureEndoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
Coils are deployed at identifiable angulated points and in sequential manner until there a cessation of flow in SPSS on doppler monitoring; glue is then injected counter to blood flow and upstream (i.e. towards spleen) from the coils to maximize intraluminal polymerization and reduce risk of embolization. Size and number of coils will vary on a case by case basis according to the size of the SPSS, and coils with a size of at least 25% larger than the size of the SPSS will be used as standard sizing. Coils will be inserted using a 19 gauge fine needle via an endoscopic ultrasound through an either transgastric/transduodenal approach.
- ProcedureInterventional Radiology for shunt embolization/retrograde tranvenous obliteration
Interventional Radiology (IR) embolization of a splenorenal shunt (specifically Spontaneous Splenorenal Shunts - SPSS) is a minimally invasive procedure, often using Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) or coils, to treat severe, refractory hepatic encephalopathy caused by blood bypassing the liver. It forces blood back through the liver, improving function, but carries risks of increased portal pressure, ascites, or worsened varices.
Location
- Rutgers University HospitalNewark, New Jersey