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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05394129
Study type Observational [Patient Registry]
Source Seoul National University Hospital
Contact Han Myung Lee, M.D.
Phone 82-2-2072-2845
Email hmlee624@naver.com
Status Recruiting
Phase
Start date April 9, 2019
Completion date December 31, 2022

See also
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