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Difficulty in recruiting research subjects
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It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurePath™ | The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1. In SurePath™ group, subjects who underwent SurePath™ liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. |
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| Conventional | The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1. In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePath™ liquid cell test with the second obtained sample. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurePath™ | Diagnostic Test | In the liquid-based cytology, a fine-needle aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | Pathologic results of the surgical specimen or core needle biopsy will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. The combined results make a final diagnosis and are compared between two groups. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Cytomorphologic feature | The investigators will evaluate the cytomorphologic features of each method. The investigators plan to investigate whether there are differences in the level of artifacts, the degree of background cleanliness, and tumor cell characteristics such as cellularity. | 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients above 19 years of age who underwent EUS-FNA for suspected esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
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| Name | Affiliation | Role |
|---|---|---|
| Han Myung Lee, M.D. | Fellowship | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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