Hepatic Encephalopathy, Liver Cirrhosis, Portal Shunt Systemic
Conditions
Brief 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.
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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 medical therapy or reoccurs shortly after fluid has been removed 2. Refractory or recurrent bleeding from esophageal varices 3. Presence of portal vein thrombosis with complete occlusion 4. Hepatocellular carcinoma beyond Milan criteria or other advanced malignancy with limited life expectancy (\<6 months) 5. Platelet count of less than 35,000 and/or INR of more than 2 which cannot be corrected for the EUS guided embolization procedure. 6. Hepatic venous occlusion, or right heart failure as the etiology of cirrhosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The severity of hepatic encephalopathy | 4 weeks after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of portal hypertensive gastrointestinal bleeding episodes | 90 days after intervention | Number of episode of gastrointestinal bleeding due to portal hypertension, complications including esophageal varices, gastric varices, portal hypertensive gastropathy and gastric antral vascular ectasia. |
| Number of hospitalization for hepatic encephalopathy after intervention | 90 days after intervention | Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention |
| Migration or systemic embolization of embolization materials | 30 days after intervention | Yes = 1; No = 0 |
| Intra-operative bleed | 30 days after intervention | Yes = 1; No = 0 |
| Development of new or worsening ascites | 30 days after intervention | Yes = 1; No = 0 |
| Development of new esophageal or gastric varices | 30 days after intervention | Yes = 1; No = 0 |
Countries
United States
Outcome results
None listed