A Prospective Randomized Trial of a New Multibending Versus Conventional Ultra-slim Endoscope for Direct Peroral Cholangioscopy Without Device Assistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
研究概览
简要总结
This study was aimed to to evaluate the efficacy of the new multibending ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC.
详细描述
Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, the investigators evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, which was defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 min.
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
- Single (Participant)
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
- •biliary disease requiring diagnostic and/or therapeutic direct POC
- •distal common bile duct (CBD) dilation > 8 mm
- •previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP
- •ability to provide informed consent
排除标准
- •presence of any contraindication to ERCP
- •bleeding tendency (international normalized ratio > 1.5 or platelet count < 50,000/ mm3)
- •diffuse stricture of the distal CBD
- •diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV)
- •altered gastrointestinal anatomy or significant duodenal obstruction
结局指标
主要结局
The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
时间窗: within 15 min after insertion of endoscope into the mouth
successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories
次要结局
- Procedure time required for free-hand insertion(the time of oral intubation with the ultra-slim endoscope to the time of reaching the obstructed segment of the biliary tree or bifurcation, within 15 min after insertion of endoscope into the mouth)
- The technical success of diagnostic and therapeutic interventions(Within 24 hours after Completion of DPOC)
- Adverse events related to direct POC(Within 7 days after DPOC)
研究者
Jong Ho Moon
Professor
Soonchunhyang University Hospital