Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of EUS Vs MRCP
研究概览
简要总结
A Recent Meta analysis, showed pooled sensitivity and specificity were 97% and 90 for EUS and 87% and 92 for MRCP . This meta analysis includes only 5 studies, smaller sample size in each study, significant heterogeneity in reference standards ranged from ERCP and Intra operative cholangiography (IOC) to clinical follow up for negative patients . Furthur validation of EUS Vs MRCP is needed in detecting common bile duct caliculi in intermediate risk of choledocholithiasis To date Randamized control trail comparing EUS Vs MRCP in detecting Choledocholithiasis lacking , hence the investigators aimed a Randamized control trail determining and comparing the sensitivity and specificity of EUS and MRCP in diagnosing Choledocholithiasis.
详细描述
Aim: Endosonography Versus Magnetic Resonance Cholangiopancreatography for Choledocholithiasis for Intermediate Risk of Choledocholithiasis (as Per European Society of Gastrointestinal Endoscopy Guidelines )- Randomized Controlled Trial
Outcomes
A.Primary Outcome :
•Sensitivity and Specificity of EUS Vs MRCP
B.Secondary Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18yrs of age with suspected choledocholithiasis stratified into intermediate risk of choledocholithiasis as per European Society of Gastrointestinal Endoscopy Guidelines
排除标准
- •Patients with Cholangitis
- •Patients with hypotension
- •Ultrasound or CT cross sectional image showing stone
- •Patients with contraindications to MRCP (claustrophobia ,pacemaker, or any prosthesis contraindicating MR)
- •Predictable impossibility to perform a complete exploration of pancreato biliary area by EUS (gastroenteroanastomosis or stenosis )
- •Patients with suspected pancreato biliary malignancy or pancreato biliary malformations
- •Patients with history significant alcohol intake
- •Patients taking hepato toxic drugs
- •Patients in whom serum hepatitis B or C antibodies are present
- •Patients with confirmed history of choledocholithiasis or history of biliary sphincterotomy
- •Patients not giving consent for participation
结局指标
主要结局
Sensitivity and Specificity of EUS Vs MRCP
时间窗: 4 month
This study will evaluate diagnostic accuracy of MRCP and EUS in patients with intermediate probability of choledocholithiasis as per European society of GI endoscopy guidelines
次要结局
- Rate of Adverse Events(4 month)
- Rate of Additional Significant Endoscopic finding(4 months)
- Cost - Effectiveness(4 months)
研究者
Rakesh K
Consultant Gastroenterologist
Asian Institute of Gastroenterology, India