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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.
background
Pancreatic cancer is the challenging malignancy in diagnosis and treatment.
Recently, EUS-FNA has played a important role in diagnosing pancreatic cancer.
Samples from EUS-FNA are sent to following three types of preparations.
In cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy.
Therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist.
Method
We are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test.
One identical and skilled endoscopist performs EUS-FNA with multiple punctures.
We get total 8 pairs of slides (= 8 covers + 8 bases).
All the cover slides are collected to the bottle-A, all the base slide to the bottle-B.
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.)
She record the positive or negative in each bottle. (If there is only one slide is positive in malignant cell, the bottle is positive.)
In these manner, we collect the all subjects' cytopathologic results as a pair of outcome. All the possible combinations are following four examples:
Then we are going to take a two-sided non-inferiority test of proportion using McNemar's test.
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| Measure | Description | Time Frame |
|---|---|---|
| positive malignancy rate of cover slides set and base slides set. | comparison between diagnostic accuracy between cover slide sets and base slide sets | cytopathological report within 2 weeks after EUS-FNA |
| Measure | Description | Time Frame |
|---|---|---|
| positive malignancy rate of (1) cytologic smear, (2) cell block and (3) histologic biopsy | comparison of three types of test in rate of positive malignancy | record of pathologist within 2 weeks after EUS-FNA |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of suspicious pancreatic cancer in radiologic study
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| Name | Affiliation | Role |
|---|---|---|
| Jaihwan Kim, M.D. | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2019 | |
| Reset | Nov 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2019 | Nov 20, 2019 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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One identical and skilled endoscopist's EUS-FNA sampling with multiple punctures
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |