Prospective Evaluation of the Accuracy of Spybite Biopsy Forceps for the Tissue Diagnosis of Lesion of the Pancreatobiliary System. ( Part of the "The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Treatment of Pancreaticobiliary Disorders" Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Accurate Diagnoses of Cancer
研究概览
简要总结
The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.
详细描述
The participants will undergo an Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy and evaluation of a bile duct or pancreatic duct stricture with three different types of techniques for biopsy: SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •Subjects is 18 years or older
- •Scheduled to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) wiht cholangioscopy and/or pancreatoscopy at the University of Florida Gainesville Florida as medically indicated.
- •Lesion of the pancreatobiliary system that requires tissue sampling as medically indicated
- •Subject myst be able to give informed consent
排除标准
- •Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- •The subject is unable to give informed consent
结局指标
主要结局
Percentage of Participants With Accurate Diagnoses of Cancer
时间窗: up to 7 days after the procedure
The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.
次要结局
- Procedure Technical Success(day 1)
- Total Procedure Time(120 minutes)
- Total Cholangioscopy Time(60 minutes)
- Adverse Events(24 hours)
- Sampling Times for Each Device(15 minutes)
- Cholangioscopy Visualization Time(30 minutes)