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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after intervention |
| Number of hospitalization for hepatic encephalopathy after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver function | change in participants MELD 3.0 and Child-Pugh scores at 30 days after intervention versus time of enrollment | 30 days after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University Hospital | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37926635 | Background | 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. | |
| 38937539 | 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. |
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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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|
| 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. |
|
Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention |
| 90 days after intervention |
| Migration or systemic embolization of embolization materials | Yes = 1; No = 0 | 30 days after intervention |
| Intra-operative bleed | Yes = 1; No = 0 | 30 days after intervention |
| Development of new or worsening ascites | Yes = 1; No = 0 | 30 days after intervention |
| Development of new esophageal or gastric varices | Yes = 1; No = 0 | 30 days after intervention |
| 30774483 | 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. |
| 26970243 | 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. |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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