Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Severe/refractory ascites defined as ascites that does not recede after medical therapy or reoccurs shortly after fluid has been removed
Refractory or recurrent bleeding from esophageal varices
Presence of portal vein thrombosis with complete occlusion
Hepatocellular carcinoma beyond Milan criteria or other advanced malignancy with limited life expectancy (<6 months)
Trial design
Treatments tested in this trial
- Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
- Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov