Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders
Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
研究概览
详细说明
Advanced imaging techniques such as SpyGlass or pCLE (probe-based Confocal laser endomicroscopy) using Cellvizio probes enable high sensitive and specific diagnosis of strictures or tumors in bile and pancreatic ducts. However, advanced endoscopists have only recently started to employ such techniques for diagnostic purposes. Hence we lack enough data to evaluate the sensitivity, specificity, accuracy, technical feasibility and safety of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate advanced imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.
The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.
This multi-center registry has been initiated:
- To document the impact of advanced imaging techniques in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
- To assess the sensitivity, specificity, accuracy, technical feasibility and safety of advanced imaging techniques in pancreatico-biliary disorders.
The registry will review and document:
- All patients who have had advanced imaging done for pancreatico-biliary disorders.
- No subject intervention is involved in this study. Subject contact is not needed for database review.
Study Design at Secondary sites:
- Other sites must have either a database review protocol and/or a clinical trial that would collect data on advanced imaging done for pancreatico-biliary disorders prior to participating in the registry.
- These sites would have IRB approved protocols to collect and send advanced imaging procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their respective protocols and consent/HIPAA forms.
- All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
- Relevant IRB documentation will be maintained at both primary and secondary sites.
研究类型
注册 (预期的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- 招聘中
- Weill Cornell Medical College
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接触:
- Monica R Gaidhane, MD
- 电话号码:646-962-4796
- 邮箱:mog2012@med.cornell.edu
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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:
- Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
- Above 18 years of age.
Exclusion Criteria:
- Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
- Below 18 years of age.
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 |
干预/治疗 |
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Endoscopic imaging
Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
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Endoscopy involving advanced imaging techniques
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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 |
---|---|---|
Efficacy Profile
大体时间:1 year
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Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Survival duration
大体时间:1 year or more
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Documentation of follow up diagnoses variable and survival duration (in days).
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1 year or more
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Efficacy
大体时间:1 year
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Documentation of technical success and clinical success rates.
Technical success will be recorded as procedure success and capturing of relevant advanced imaging.
Clinical success will be recorded as if a diagnosis was made based on the advanced imaging results.
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1 year
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Safety Profile
大体时间:30 days
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Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
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30 days
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合作者和调查者
出版物和有用的链接
一般刊物
- Tyberg A, Xu MM, Gaidhane M, Kahaleh M. Second generation optical coherence tomography: Preliminary experience in pancreatic and biliary strictures. Dig Liver Dis. 2018 Nov;50(11):1214-1217. doi: 10.1016/j.dld.2018.05.019. Epub 2018 Jun 8.
- Karia K, Waxman I, Konda VJ, Gress FG, Sethi A, Siddiqui UD, Sharaiha RZ, Kedia P, Jamal-Kabani A, Gaidhane M, Kahaleh M. Needle-based confocal endomicroscopy for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc. 2016 May;83(5):924-7. doi: 10.1016/j.gie.2015.08.080. Epub 2015 Sep 14.
- Karia K, Jamal-Kabani A, Gaidhane M, Tyberg A, Sharaiha RZ, Kahaleh M. Probe-Based Confocal Endomicroscopy in Primary Sclerosing Cholangitis: Not All Inflammatory Strictures Are the Same. Dig Dis Sci. 2016 Jan;61(1):283-6. doi: 10.1007/s10620-015-3827-1. Epub 2015 Aug 2.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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 (实际的)
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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Diagnosis of a Pancreaticobiliary Disorder的临床试验
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Swansea University完全的