Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
研究概览
简要总结
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
详细描述
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection
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
- •Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
- •Diameter of pancreatic main duct >5mm on pre-operative MRI or CT
- •Written informed consent from patient to participate in the study, including compliance with study procedures
排除标准
- •Contraindication for pancreatoscopy
- •Age: less than 18 years
- •Pregnant women, evaluated per local clinical standard
研究组 & 干预措施
Intraoperative Pancreatoscopy
All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.
干预措施: SpyGlass (Device)
结局指标
主要结局
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct
时间窗: During index procedure
Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies
次要结局
- Adverse Event Evaluation(Five years)
- Comparison of visual and biopsy diagnosis(During index procedure)
- Recurrence(Five years)
- Inter-observer correspondence of visual impression of IPMN(During index procedure)
- Technical success(During index procedure)