SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions

Study Overview
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Brief Summary
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The SurePathTM has been approved by the FDA since 1997. Currently, the SurePathTM is used for endometrial cells, body fluids, bronchoscopy aspirates, and thyroid fine needle aspirates. There is an advantage that the denaturation is small, the density of the cells is uniform, and the read area is small so that the read time can be shortened. Therefore, investigators plan to apply the SurePathTM test for pancreatic EUS-FNA specimens. Morphological comparative analysis is needed before completely replacing the existing classical smear test method. The aim of this study is to confirm that the SurePathTM is not inferior and is more accurate than the classical smear test.

Official Title
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A Prospective Comparison of SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Pancreatic Lesions

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: SurePathTM


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 pancreatic cancer from radiological examinations (CT, MR, ultrasound) Exclusion Criteria: Those who did not agree with the study Patients older than 18 years of age Serious mental patients Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, poorly controlled blood sugar) 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: 18 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 |
| --- | --- |
| SurePathTM<br>The subjects are randomly assigned to SurePathTM/Conventional test group at a ratio of 1: 1. In SurePathTM group, subjects who underwent SurePathTM liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. | Diagnostic Test: SurePathTM<br>* In the liquid-phase cytology, a fine-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 SurePathTM/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 SurePathTM liquid cell test with the second obtained sample. | Diagnostic Test: SurePathTM<br>* In the liquid-phase cytology, a fine-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 | If surgical treatment is performed after the examination, pathologic results of the surgical specimen and record 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. Additional tests performed at this time are subject to the clinician's decision according to the clinical situation of each patient. 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 |
| --- | --- | --- |
| Sensitivity | The proportion of positives that are correctly identified as such. | 6 months after randomization | 
| Specificity | The proportion of negatives that are correctly identified as such | 6 months after randomization |