Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to final diagnosis
研究概览
简要总结
The purpose of this investigator-initiated study is to determine whether a single-step session that combines endoscopic ultrasound (which may further include liver biopsy and needle-guided cholangiography) with endoscopic cholangiopancreatography (ERCP) can facilitate in the management of liver graft dysfunction. All patients will undergo the same procedural protocol.
详细描述
Liver graft dysfunction can arise from many disease processes, which include biliary obstruction, rejection, infection and ischemia. Battery of tests, and at times empiric therapy, is necessary to obtain final diagnosis. This results in waste of time and medical resources that can lead to delay in care, which may ultimately translate to increase morbidity and mortality, as well as increase in cost.
In this protocol, the investigators propose utilization of interventional endoscopy for the diagnosis and treatment of liver graft dysfunction. Use of endoscopic ultrasound (EUS) with possible liver biopsy and cholangiography, and endoscopic retrograde cholangiopancreatography in one session may facilitate diagnosis and treatment. All patients enrolled in this protocol will undergo the same procedural protocol. The quality of care metrics in these patients (such as length of stay, cost, mortality, etc), will be compared to that of historical controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •All hospitalized patients with liver graft dysfunction
排除标准
- •Thrombocytopenia (platelets <50.000/mL) until corrected
- •Coagulopathy (international normalized ratio (INR) >1.5) until corrrected
- •Use of thrombolytic or anti-platelet agents within 5-7 days of the procedure.
- •Any with known bleeding diathesis will be excluded. (e.g. disseminated intravascular coagulation (DIC), von-Willebrand disease, hemophilia).
- •Those who had recent prior liver biopsy or EUS/ERCP will be excluded.
- •Those with active bacteremia will be excluded, at least until treated.
- •For this initial study, those with altered GI tract anatomy (e.g. those with hepaticojejunostomy or gastro-jejunostomy) will be excluded
结局指标
主要结局
Time to final diagnosis
时间窗: Up to 30 days
Time from first diagnostic test to final diagnosis
次要结局
未报告次要终点