NCT04580940已完成不适用
Flexible Percutaneous Transhepatic Cholangiopancreatoscopy (PTCS) in Complex Pancreaticobiliary Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Achieving clinical intent of procedure as indicated
研究概览
简要总结
To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series
详细描述
This case series aims to illustrate the clinical utility of percutaneous transhepatic cholangiopancreatoscopy using a thin, disposable, flexible endoscope performed by gastroenterological endoscopists and/or interventional radiologists in procedures including but not limited to:
- PTCS for tissue diagnosis in cases of surgically or pathologically-altered anatomy,
- PTCS for stone removal after surgically or pathologically-altered anatomy,
- Percutaneous rendezvous to aid ERCP after failed endoscopic cannulation,
- Percutaneous delivery of palliative intraluminal brachytherapy,
- Intra-procedural percutaneous salvage procedures when an initial route of access fails
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice
- •Written informed consent from patient or legally authorized representative of the patient
排除标准
- •Contraindication for cholangiopancreatoscopy
- •Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access
- •<18 years of age
- •Potentially vulnerable subjects, including, but not limited to pregnant women
结局指标
主要结局
Achieving clinical intent of procedure as indicated
时间窗: 1 month
Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS.
次要结局
- Number of Adverse Events(1 month)
- Technical success(During index procedure)
- Procedural Time(During index procedure)
- Endoscopist rating(During index procedure)
- Number of PTCS procedures(1 month)
研究者
研究点 (7)
Loading locations...
相似试验
尚未招募
4 期
se of SpyGlass Discover Digital System during a percutaneous transhepatic cholangiopancreatoscopy procedure.CTRI/2021/11/037874Boston Scientific Corporation
终止
4 期
Percutaneous Endoluminal Benign Biliary LaserBenign Biliary Strictures With Current or Prior Biliary ObstructionNCT05567003University of California, Los Angeles5
尚未招募
不适用
Role of gall bladder cholangiography in evaluation of infants suspected with absence of bile ductsCTRI/2020/03/023956Vivek Kumar Garg
招募中
不适用
Efficacy and safety of cholangiopancreatoscopy: multicenter prospective observation studyPancreatobiliary diseases in need of cholangiopancreatoscopyJPRN-UMIN000023450Digestive and Lifestyle Diseases, Kagoshima University50
已完成
不适用
Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography AccessBiliary StrictureNCT06096129Rigshospitalet, Denmark22