Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- occurrence of adverse biliary events
研究概览
简要总结
The main objective of this study is to assess the effectiveness and costs of magnetic resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct obstruction on ultrasound. The investigators do not anticipate that a universal recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all patients presenting with bile duct obstruction. Rather, the investigators hope to provide quantitative and comparative data relevant to the different clinical situations likely to be encountered in practice, in order to assist physicians in choosing the appropriate diagnostic modality. More specifically, the investigators feel that patients with intrahepatic or hilar obstruction (particularly those with malignant conditions), and those with partial common bile duct (CBD) obstruction (to rule out suspected choledocholithiasis) will benefit most from this new technology and the avoidance of an unnecessary ERCP to further determine the biliary anatomy.
详细描述
The approach to investigation and management of intermediate-risk biliary obstruction is controversial. Both magnetic resonance cholangiopancreatography(MRCP)and endoscopic retrograde cholangiopancreatography (ERCP) are used interchangeably in practice, with little literature to support the efficacy of one versus the other.
The purpose is to assess the effectiveness of MRCP compared to ERCP in the initial work-up of patients at intermediate risk of suspected biliary obstruction following initial clinical assessment and ultrasonography.
A randomized medical effectiveness study was conducted across three tertiary care hospital sites. Patients at intermediate risk of biliary obstruction were randomized to either ERCP or MRCP based on level of obstruction as seen by ultrasound (US).
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
- •Age greater than 18 years
- •Elevated bilirubin (>30 umol/L)
- •CBD dilatation on ultrasound: greater than 7 mm wide with gallbladder in situ, or 10mm wide in patient post-cholecystectomy
- •Suspected or detected gallstone on ultrasound
排除标准
- •Low probability of biliary tract disease
- •Active cholangitis
- •Bilio-pancreatic pathology identified on ultrasound or CT scan
- •Any clinical condition precluding MRCP or ERCP: severe cardio-respiratory disease, pregnancy, significant coagulopathy (INR over 1.5)
- •Presence of Roux-en-Y bilio-enteric anastomosis
- •Any metallic implant making ERCP or MRCP hazardous
- •ERCP or MRCP performed within 6 months prior to study inclusion
结局指标
主要结局
occurrence of adverse biliary events
时间窗: 12 months
The goal of this study was to evaluate the effectiveness of MRCP compared to ERCP in assessment of patients at intermediate risk for suspected biliary obstruction
次要结局
- complication-related length of stay(12 months)
- Number of additional procedures (i.e ERCP, MRCP, US...)(12 months)
- mortality(12 months)
研究者
Alan Barkun
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre