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NCT Number: NCT07553858

Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Shunt Systemic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University Hospital

Newark, New Jersey, 07103, United States

Location contact

Kaveh Hajifathalian, MD

CONTACT

[email protected]

973-972-9814

Kaveh Hajifathalian, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The severity of hepatic encephalopathy

    Time frame: 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 outcomes

  1. Number of portal hypertensive gastrointestinal bleeding episodes

    Time frame: 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.

  2. Number of hospitalization for hepatic encephalopathy after intervention

    Time frame: 90 days after intervention

    Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention

  3. Migration or systemic embolization of embolization materials

    Time frame: 30 days after intervention

    Yes = 1; No = 0

  4. Intra-operative bleed

    Time frame: 30 days after intervention

    Yes = 1; No = 0

  5. Development of new or worsening ascites

    Time frame: 30 days after intervention

    Yes = 1; No = 0

  6. Development of new esophageal or gastric varices

    Time frame: 30 days after intervention

    Yes = 1; No = 0

Other outcomes

  1. Change in liver function

    Time frame: 30 days after intervention

    change in participants MELD 3.0 and Child-Pugh scores at 30 days after intervention versus time of enrollment

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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