Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy

NCT07553858 | Not Yet Recruiting DMC

• 1 other identifier: Pro2025000948
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 1.Does EUS guided embolization maintain an acceptable safety profile?
2. 2.Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?
3. 3.Receive EUS guided embolization or medical management.
4. 4.Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).
5. 5.Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; Portal Shunt Systemic

Outcome Measures

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.

  4 weeks after intervention

Secondary Outcomes (6)

• Number of portal hypertensive gastrointestinal bleeding episodes

  90 days after intervention

• Number of hospitalization for hepatic encephalopathy after intervention

  90 days after intervention

• Migration or systemic embolization of embolization materials

  30 days after intervention

• Intra-operative bleed

  30 days after intervention

• Development of new or worsening ascites

  30 days after intervention

Other Outcomes (1)

• Change in liver function

  30 days after intervention

Study Arms (2)

Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt

ACTIVE COMPARATOR

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.

Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration

Endoscopic ultrasound guided embolization of shunt

EXPERIMENTAL

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.

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

Interventions

Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts PROCEDURE

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.

Endoscopic ultrasound guided embolization of shunt

Interventional Radiology for shunt embolization/retrograde tranvenous obliteration PROCEDURE

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.

Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Platelet count of less than 35,000 and/or INR of more than 2 which cannot be corrected for the EUS guided embolization procedure.
• Hepatic venous occlusion, or right heart failure as the etiology of cirrhosis.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (4)

• Yang M, Qiu Y, Wang W. Concurrent spontaneous portosystemic shunt embolization for the prevention of overt hepatic encephalopathy after TIPS: A systematic review and meta-analysis. Dig Liver Dis. 2024 Jun;56(6):978-985. doi: 10.1016/j.dld.2023.10.013. Epub 2023 Nov 3.

  PMID: 37926635 BACKGROUND

• Ke Q, He J, Cai L, Lei X, Huang X, Li L, Liu J, Guo W. Safety and efficacy of interventional embolization in cirrhotic patients with refractory hepatic encephalopathy associated with spontaneous portosystemic shunts. Sci Rep. 2024 Jun 27;14(1):14848. doi: 10.1038/s41598-024-65690-1.

  PMID: 38937539 BACKGROUND

• Philips CA, Rajesh S, Augustine P, Padsalgi G, Ahamed R. Portosystemic shunts and refractory hepatic encephalopathy: patient selection and current options. Hepat Med. 2019 Jan 25;11:23-34. doi: 10.2147/HMER.S169024. eCollection 2019.

  PMID: 30774483 BACKGROUND

• Lynn AM, Singh S, Congly SE, Khemani D, Johnson DH, Wiesner RH, Kamath PS, Andrews JC, Leise MD. Embolization of portosystemic shunts for treatment of medically refractory hepatic encephalopathy. Liver Transpl. 2016 Jun;22(6):723-31. doi: 10.1002/lt.24440.

  PMID: 26970243 BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Advanced Endoscopy

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)