Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy

Rutgers The State University of New Jersey

Status: Not yet enrolling

Conditions: Hepatic Encephalopathy; Liver Cirrhosis; Portal Shunt Systemic

Treatments: Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts; Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration

Study type: Interventional

Funder types: Other

Identifiers

NCT07553858

Pro2025000948

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt

Active Comparator group

Description:

Embolization of the porto-systemic shunt will be conducted via Trans-Jugular, Trans-Femoral, or direct Trans-hepatic access to embolize the shunt using cyanoacrylate glue, Sodium TetraDecyl Sulfate, Gelfoam, and/or vascular coil injection. The procedure will be performed under deep sedation or general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.

Treatment:

Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration

Endoscopic ultrasound guided embolization of shunt

Experimental group

Description:

Embolization of the porto-systemic shunt will be performed via endoscopic ultrasound (EUS) transesophageal or transgastric access with a 19G fine-needle aspiration (FNA) EUS needle to embolize the shunt using cyanoacrylate glue and vascular coil injection. The procedure will be performed under general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.

Treatment:

Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts