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2018-04-17
2019-06-30
2019-12-31
170
NCT03606148
Seoul National University Hospital
Seoul National University Hospital
OBSERVATIONAL
SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-04-26 | N/A | 2019-01-21 |
2018-07-27 | N/A | 2019-01-23 |
2018-07-30 | N/A | 2018-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : SurePathTM 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 | DIAGNOSTIC_TEST: SurePathTM
|
| : Conventional 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 secon | DIAGNOSTIC_TEST: SurePathTM
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sang Hyub Lee, MD. PhD. Phone Number: +82-2-2072-4892 Email: gidoctor@snuh.org |
Study Contact Backup Name: Min su You, MD Phone Number: +82-2-2072-3168 Email: bass105@hanmail.net |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
