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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
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.
Rutgers University Hospital
Newark, New Jersey, United States
The severity of hepatic encephalopathy
Grade of worst episode of hepatic encephalopathy (HE) during a 4-week period after intervention as measured by West Haven criteria at one week intervals after intervention, (see below for a copy of West Haven Criteria) administered via telephone encounters by study personnel. West Haven Criteria: * Grade 0 (Minimal/Covert): No detectable changes in personality or behavior; minimal deficits in fine motor skills or psychometric tests. * Grade 1 (Covert): Mild lack of awareness, shortened attention span, mild personality changes, and/or sleep-wake cycle disturbances. * Grade 2 (Overt): Lethargy or apathy, moderate disorientation to time, obvious personality changes, inappropriate behavior, and sometimes asterixis (flapping tremor). * Grade 3 (Overt): Severe confusion, stupor, somnolence, and disorientation to place/situation, but the patient remains rousable. * Grade 4 (Overt): Coma, with or without response to painful stimuli.
Time frame: 4 weeks after intervention
Number of portal hypertensive gastrointestinal bleeding episodes
Number of episode of gastrointestinal bleeding due to portal hypertension, complications including esophageal varices, gastric varices, portal hypertensive gastropathy and gastric antral vascular ectasia.
Time frame: 90 days after intervention
Number of hospitalization for hepatic encephalopathy after intervention
Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention
Time frame: 90 days after intervention
Migration or systemic embolization of embolization materials
Yes = 1; No = 0
Time frame: 30 days after intervention
Intra-operative bleed
Yes = 1; No = 0
Time frame: 30 days after intervention
Development of new or worsening ascites
Yes = 1; No = 0
Time frame: 30 days after intervention
Development of new esophageal or gastric varices
Yes = 1; No = 0
Time frame: 30 days after intervention
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