Hepatic EncephalopathyNCT07553858
Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy
A study testing Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts and Interventional Radiology for shunt embolization/retrograde tranvenous obliteration in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis, Portal Shunt Systemic
- What is being tested?
- Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts and Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers University Hospital
Newark, New Jersey, 07103
Kaveh Hajifathalian, MD, 973-972-9814, kh852@njms.rutgers.edu
Kaveh Hajifathalian, MD
About this study
Official title: Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized 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:
- Does EUS guided embolization maintain an acceptable safety profile?
- Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?
Read more
Participants will:
- Receive EUS guided embolization or medical management.
- Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).
- Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.
- Being tested
- Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts, Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shuntsProcedure or surgery
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 obliterationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after intervention
Secondary outcomes (6)
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.
Measured: 90 days after intervention
Number of hospitalization for hepatic encephalopathy after intervention
Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention
Measured: 90 days after intervention
Migration or systemic embolization of embolization materials
Yes = 1; No = 0
Measured: 30 days after intervention
Intra-operative bleed
Yes = 1; No = 0
Measured: 30 days after intervention
Development of new or worsening ascites
Yes = 1; No = 0
Measured: 30 days after intervention
Development of new esophageal or gastric varices
Yes = 1; No = 0
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaveh Hajifathalian, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553858
- Sponsor's protocol ID
- Pro2025000948
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be recorded by study ID # (Pro2025000948) according to Rutgers University policy. Data will be securely stored via Microsoft One Drive Account under password protected RU secure network, only accessible by principle investigator.
Publications
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.
PubMed 37926635Ke 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.
PubMed 38937539Philips 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.
PubMed 30774483Lynn 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.
PubMed 26970243
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07553858
- Acronym / sponsor ID
- Pro2025000948
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does EUS guided embolization maintain an acceptable safety profile?
- Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?
Participants will:
- Receive EUS guided embolization or medical management.
- Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).
- Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt | Active comparator | Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliterationEmbolization 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. |
| Endoscopic ultrasound guided embolization of shunt | Experimental | Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shuntsEmbolization 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shuntsCoils 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. | Procedure or surgery | Endoscopic ultrasound guided embolization of shunt |
| Interventional Radiology for shunt embolization/retrograde tranvenous obliterationInterventional 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. | Procedure or surgery | Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt |
Primary outcome
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.
6 secondary outcomes
Number of portal hypertensive gastrointestinal bleeding episodes
Time frame: 90 days after intervention
Number of hospitalization for hepatic encephalopathy after intervention
Time frame: 90 days after intervention
Migration or systemic embolization of embolization materials
Time frame: 30 days after intervention
Intra-operative bleed
Time frame: 30 days after intervention
Development of new or worsening ascites
Time frame: 30 days after intervention
Development of new esophageal or gastric varices
Time frame: 30 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 37926635Yang 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.
- Background: PubMed 38937539Ke 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.
- Background: PubMed 30774483Philips 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.
- Background: PubMed 26970243Lynn 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.
- Individual participant dataSharing planned: No. Data will be recorded by study ID # (Pro2025000948) according to Rutgers University policy. Data will be securely stored via Microsoft One Drive Account under password protected RU secure network, only accessible by principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts and Interventional Radiology for shunt embolization/retrograde tranvenous obliteration in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of hepatic encephalopathy (time frame: 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553858, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.