Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
研究概览
简要总结
Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic precondition. Other than the conventional mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at the side of a specially developed duodenoscope (mother part) which is prepositioned distally to the control unit, near to the patient's mouth. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. This study is designed to test the efficiency of the device in relation to this assumption.
详细描述
Cholangioscopy is a subsidiary treatment in endoscopic retrograde cholangiopancreaticography (ERCP), used for special issues. In the context of ERCP, a long,thin shaped device is introduced through the working channel of a duodenoscope and then through the papilla into the biliary duct.
Inspection of the biliary duct can be used for tumor biopsies as well as for gall stone lithotripsy by laser or electrohydraulic technique.
Manoeuverability of cholangioscopes is limited by the length of the scope, even more, since most of the device body is stuck in the working channel.
The newly designed cholangioscope by the company of Karl Storz GmbH is introduced through a shortened working channel. Introduction of the cholangioscope is done by an innovative side port for the cholangioscope at 70 cm from the insertion tube's distal end. This leads to a better flexibility of the device tip. Better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres.
This study is designed to test the efficiency of the device in relation to this assumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Choledocholithiasis, not treatable through conventional ERCP with sphincterotomy.
- •Stricture of the biliary duct in need of histopathological investigation
排除标准
- •Aggravated or impossible access to papilla
- •Inappropriate biliary anatomy, e.g. multiple strictures or diameter of duct < cholangioscope impairing intubation
- •Primary sclerosing cholangitis
- •Coagulopathy (quick < 50%, thrombocytes < 50/nl)and anticoagulant medication
- •Bad patient's condition (ASA IV)
研究组 & 干预措施
Frimberger cholangioscope
Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
干预措施: cholangioscopy (Frimberger) (Device)
结局指标
主要结局
Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
时间窗: Patients will be monitored during stay in hospital, average stay is 1 day
1. complete lithotripsy in a single session 2. rate of right positive malignoma diagnostics (sensitivity)
次要结局
- Complication rate(while examination and 24 hrs past examination)
- Gallstone therapy(procedure, average procedure time 1 hour)
- Stricture diagnostic(procedure, average procedure time is 1 hour)