Diagnostic Accuracy of SurePath™ in EUS-FNA

Study Overview
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Brief Summary
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It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ulatrasound-guided sampling.

Detailed Description
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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.

Official Title
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A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes

Conditions
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Submucosal Tumor of Gastrointestinal Tract

Intervention / Treatment
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* Diagnostic Test: SurePath™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who signed the agreement after the explanation Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations. Exclusion Criteria: Those who did not agree with the study Patients younger than 19 years of age Serious mental patients Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness) Pregnant women If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y) Patient with blood clotting abnormality If there is a risk of tract seeding after examination

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SurePath™<br>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. | Diagnostic Test: SurePath™<br>* 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.<br>|
| Conventional<br>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. | Diagnostic Test: SurePath™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytomorphologic feature | We will evaluat the cytomorphologic features of each method. We 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 |