Comparison Between Mechanical Intracanal (ML) Lithotripsy and Electrohydraulic Intracolangioscopic (EHL) Lithotripsy in the Treatment of Difficult Main Biliary Tract Lithiasis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ML - EHL comparison
研究概览
简要总结
Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy.
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
详细描述
Difficult gallstones are found in about 10-15% of endoscopic retrograde cholangiopancreaticography (ERCP) performed for choledocholithiasis. There are several options for the treatment of difficult biliary lithiasis including mechanical lithotripsy and peroral cholangioscopy with electrohydraulic lithotripsy.
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session.
The secondary objectives of the study are as follows:
- Within 30 days of the procedure, the effective clearance of the biliary tract will be assessed with CholangioRM (or EUS where MRI is contraindicated). If residual choledocholithiasis is present, patients will be considered as late failures.
- Comparison of the safety of the treatments under study, defined by the incidence of adverse events during the procedure (e.g. perforation, hemobilia) and in the observation period after the procedure (e.g. cholangitis, pancreatitis, bleeding).
Patients that can be enrolled:
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
- •All patients with "difficult" biliary tract lithiasis that could not be treated by standard techniques, such as balloon and/or basket catheter under fluoroscopic vision.
排除标准
- •surgically-altered gastrointestinal anatomy
- •any evidence of biliopancreatic malignancy
- •patients under 18 years of age
- •patients in a state of pregnancy or are breastfeeding
- •no informed consent
结局指标
主要结局
ML - EHL comparison
时间窗: 1 day
The primary purpose of this study is to compare the effectiveness of treating difficult biliary lithiasis with ML and with EHL. The effectiveness is defined by the complete cleanliness of the biliary tract in a single endoscopic session
次要结局
- effective clearance of the biliary tract(30 days)
- Comparison of the safety of the treatments under study(30 days)