Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The severity of hepatic encephalopathy
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt
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.
干预措施: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration (Procedure)
Endoscopic ultrasound guided embolization of shunt
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.
干预措施: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts (Procedure)
结局指标
主要结局
The severity of hepatic encephalopathy
时间窗: 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.
次要结局
- 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)
- Development of new esophageal or gastric varices(30 days after intervention)
研究者
Kaveh Hajifathalian, MD
Program Director, Advanced Endoscopy
Rutgers, The State University of New Jersey