pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)
研究概览
地位
详细说明
This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.
The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.
Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.
These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Roma、意大利、00168
- Policlinico Univertitario Agostino Gemelli
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Marseille、法国、13000
- Institut Paoli Calmettes
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Connecticut
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New Haven、Connecticut、美国、06510
- Yale New Haven Hospital
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New York
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New york、New York、美国、10065
- New York Presbyterian Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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Washington
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Seattle、Washington、美国、98111
- Virginia Mason Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female > 18 years of age
- Indicated for ERCP for indeterminate bile duct stricture
- Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or
- Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
- Subjects for whom ERCP procedures are contraindicated
- Known allergy to fluorescein dye
- Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
- Patients with post-transplant stricture
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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pCLE
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
大体时间：12 months
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Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie.
number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
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12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
大体时间：12 months follow-up
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12 months follow-up
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合作者和调查者
调查人员
- 首席研究员：Adam Slivka, MD、University of Pittsburh Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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