Comparison of the Diagnostic Accuracy Between Base and Cover Slide Smear After Endoscopic Ultrasound Guided Fine Needle Aspiration for Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- positive malignancy rate of cover slides set and base slides set.
研究概览
简要总结
The purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from EUS-FNA cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.
详细描述
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background
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Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
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Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
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Samples from EUS-FNA are sent to following three types of preparations.
- cytologic smear (by pull apart method)
- cell block
- histologic biopsy
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In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
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Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
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Method
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We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
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One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
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We get total 8 pairs of slides (= 8 covers + 8 bases).
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All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
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One identical and skilled pathologist inspects these slide in blind method. (She cannot show the label of bottle so that she does not know what bottle is A or B.)
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She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
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In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:
- (cover/base) = (positive/positive) = (+/+)
- (cover/base) = (positive/negative) = (+/-)
- (cover/base) = (negative/positive) = (-/+)
- (cover/base) = (negative/negative) = (-/-)
- Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or Positron Emission Tomography.
排除标准
- •failed smear due to inexperienced assistant
- •loss of slide
- •patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests.
- •patients who refuse to participate in this study
- •report of other pathologist who are not a previously-assigned pathologist
结局指标
主要结局
positive malignancy rate of cover slides set and base slides set.
时间窗: cytopathological report within 2 weeks after EUS-FNA
comparison between diagnostic accuracy between cover slide sets and base slide sets
次要结局
- positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy(record of pathologist within 2 weeks after EUS-FNA)