NCT05822635已完成不适用
Intraoperative Endoscopy Using a Thin, Single-Use, Flexible Cholangiopancreatoscope
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Technical success
研究概览
简要总结
- To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study
详细描述
This case series aims to document the clinical utility of intraoperative endoscopy using a thin, disposable, flexible cholangiopancreatoscope in procedures including but not limited to:
- Evaluation of biliary lesion(s) during surgical management of common bile duct (CBD) and intrahepatic duct (IHD) strictures, with or without biopsy
- Transcystic/transcholedochal clearance of biliary stone(s)/sludge/cast with or without mechanical, electrohydraulic or laser lithotripsy
- Treatment of hepatolithiasis
- Assessment of communication between the biliary tree and the cyst in the setting of ruptured hydatid parasitic cysts or abcesses
- Visualization of intraductal papillary mucinous neoplasm (IPMN) lesion(s) with or without biopsy
- Assessment of pancreatic duct (PD) strictures in chronic pancreatitis, with or without biopsy
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
- •Clinical indication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- •Written informed consent from patient or legally authorized representative of the patient
排除标准
- •Contraindication for intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope
- •<18 years of age
- •Potentially vulnerable subjects, including, but not limited to pregnant women
结局指标
主要结局
Technical success
时间窗: During study procedure
Perform intraoperative endoscopy as intended using a thin, single-use, flexible cholangiopancreatoscope as desired, including but not limited to: * Direct visualization of target lesion or stricture * Obtaining biopsies * Initiating and/or completing stone clearance
次要结局
- Number of adverse events(1 month)
- Endoscopist rating of clinical impact of study procedure(During study procedure)
- Endoscopist rating of device(During study procedure)
- Adequate diagnostic yield(1 month)
研究者
研究点 (5)
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