Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Successful ERCP or EUS
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology patients at the Los Angeles County Hospital presents a unique and diverse patient population.
Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI cancer diagnosis and management, and the management of pancreaticobiliary problems in the underserved.
All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be enrolled in the databaseThe timing, clinical presentation, and objective details of patient presentation are recorded prospectively. Additionally the results of the subsequent ERCP and EUS procedures. Subsequent, clinical course and pathology will also be recorded.
详细描述
AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the management of these patients. C) Analyze how EUS and ERCP results correlate with other radiographic methods including conventional ultrasound and computed tomography (CT) D) Compare role of EUS and ERCP in a safety net versus tertiary care center
II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been demonstrated to be the least invasive and most effective means to acquire tissue in a number of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its diagostic uses are now more limited with the advent of EUS and cross sectional radiographic studies including CT and magnetic resonance cholangiopancreatography (MRCP).
A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham, Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota) have developed ERCP/EUS databases which have led to important insight about the role of these procedure and the diseases they are used to manage. However, these groups and indeed almost the entire world literature regarding EUS and ERCP focuses on America, Western European, and Japanese populations.
The goal of this database will be to study the impact of EUS and ERCP on an underserved population at LAC. The prevalence of certain diseases including cholangitis, large bile duct stones, and gastric cancer are markedly higher at our institution than in other western facilities presenting a unique opportunity to report how they are treated as part of standard management.
IIIA) DESIGN AND METHODOLOGY
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as standard of clinical care will be enrolled.
排除标准
- •None of the patients will be excluded.
结局指标
主要结局
Successful ERCP or EUS
时间窗: 1 year
Completed ERCP or EUS in which objectives of procedure were met.Unsuccessful ERCP will be classified as secondary to technical (such as failed cannulation or stent placement) versus sedation failure in which patient could not be sedated.
次要结局
- Bile Duct Stone(1 year)
- Length of Hospitalization(1 year)
- Definitive Diagnosis(1 year)
研究者
James Buxbaum
Director of Endoscopy, Los Angeles County Hospital
University of Southern California