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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.

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.

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.

SurePath™

Han Myung Lee, M.D.

Soo-Jeong Cho, M.D., Ph.D.

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

Diagnostic Accuracy of SurePath™ in EUS-FNA

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diagnostic Accuracy of SurePath™ in EUS-FNA	NCT05394129	Submucosal Tumo...	SurePath™	19 Years -	Seoul National University Hospital
Diagnostic Accuracy of SurePath™ in EUS-FNA	NCT05394129	Submucosal Tumo...	SurePath™	19 Years -	Seoul National University Hospital

Spots Global Cancer Trial Database for surepath™

Every month we try and update this database with for surepath™ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for surepath™

Every month we try and update this database with for surepath™ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for surepath™ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.