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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
Procedure/SurgeryCoils 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 for shunt embolization/retrograde tranvenous obliteration
Procedure/SurgeryInterventional 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Interventional Radiology guided embolization/retrograde tranvenous obliteration of shuntActive comparator 1 intervention
Group B: Endoscopic ultrasound guided embolization of shuntExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
Migration or systemic embolization of embolization materials
Yes = 1; No = 0
Time frame
30 days after intervention4
Intra-operative bleed
Yes = 1; No = 0
Time frame
30 days after interventionOther outcomes
1
Change in liver function
change in participants MELD 3.0 and Child-Pugh scores at 30 days after intervention versus time of enrollment
Time frame
30 days after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: