Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts
  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 siz
• Процедура Interventional Radiology for shunt embolization/retrograde tranvenous obliteration
  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.

Первичные конечные точки

• The severity of hepatic encephalopathy [Срок оценки: 4 weeks after intervention]

Вторичные конечные точки (6)

• Number of portal hypertensive gastrointestinal bleeding episodes [Срок оценки: 90 days after intervention]
• Number of hospitalization for hepatic encephalopathy after intervention [Срок оценки: 90 days after intervention]
• Migration or systemic embolization of embolization materials [Срок оценки: 30 days after intervention]
• Intra-operative bleed [Срок оценки: 30 days after intervention]
• Development of new or worsening ascites [Срок оценки: 30 days after intervention]
• Development of new esophageal or gastric varices [Срок оценки: 30 days after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rutgers University Hospital — Newark

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07553858 · Pro2025000948

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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