Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy (PANCOBE)
Pancreatic Core Biopsy Needle Study (PANCOBE)
研究概览
详细说明
Pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential. Endoscopic ultrasonography (EUS) is highly accurate regarding the detection of pancreatic cancer, and EUS guided fine-needle aspiration biopsy (EUS-FNA) may be used to verify the diagnosis in patients with non-resectable or metastatic disease. However, EUS-FNA is only diagnostic in approximately 70% of the cases, and the reported number of "atypical", "suspicious" and "insufficient" biopsies varies.
SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic tissue fractions ("trucut biopsies") instead of single cells or cluster of cells. Preliminary data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically feasible without increasing the number of complications.
This prospective study evaluates the clinical outcome and potential complications following EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge SharkCore needle.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Odense、丹麦、5000
- Odense University Hospital
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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
描述
Inclusion Criteria:
- Pancreatic lesion suspected of malignancy and EUS biopsy indicated
Exclusion Criteria:
- Resectable pancreatic lesions
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：EUS biopsy
EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of conclusive biopsies
大体时间：minimum 6 moths after biopsy
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minimum 6 moths after biopsy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Complications
大体时间：2 weeks after biopsy
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All contacts to the secondary health care system
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2 weeks after biopsy
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Quality test of biopsies
大体时间：2 weeks after biopsy
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Biopsies divided into: 1) diagnostic 2a) if not diagnostic - representative material 2b) if not diagnostic - not representative material 3) Insufficient material |
2 weeks after biopsy
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合作者和调查者
调查人员
- 研究主任：Michael B Mortensen, Professor、Odense University Hospital, University of Southern denmark
出版物和有用的链接
一般刊物
- Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
- Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
- Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. doi: 10.1055/s-2005-861142.
- Bardales RH, Stelow EB, Mallery S, Lai R, Stanley MW. Review of endoscopic ultrasound-guided fine-needle aspiration cytology. Diagn Cytopathol. 2006 Feb;34(2):140-75. doi: 10.1002/dc.20300.
- Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
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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SharkCore (TM) FNB Exchange System的临床试验
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Johns Hopkins University撤销
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Newcastle-upon-Tyne Hospitals NHS TrustMedtronic完全的
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Philipps University Marburg Medical Center未知