Comparison of Confocal Laser Endomicroscopic IN Vivo Diagnosis and EX Vivo Examination (INDEX Study) Against Surgical Histopathology of Cystic Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)
研究概览
简要总结
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.
详细描述
The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •For in vivo nCLE (needle-based confocal laser endomicroscopy) (Part 1):
- •Patient age 18 years and older
- •All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion)
- •The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies.
- •For ex vivo pCLE (probe-based confocal laser endomicroscopy) (Part 2):
- •All patients must satisfy inclusive criteria for in vivo nCLE.
- •All patients should have completed EUS-guided nCLE.
- •All patients should have a CPL lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology).
- •Patient participated and completed in vivo nCLE (Part 1)
排除标准
- •Unable to obtain informed consent
- •Unable to tolerate the procedure
- •Women with known pregnancy at time of procedure
- •Patient age less than 18 years
- •Bleeding diathesis
- •Lesion not accessible by EUS guided FNA
- •Allergy to fluorescein.
结局指标
主要结局
Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)
时间窗: 12 months
Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs.
次要结局
- Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging(12 months)
- CLE imaging interpretation variation(12 months)
研究者
Somashekar Krishna
Assistant Professor-Clinical
Ohio State University