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

Seoul National University

Status: Unknown

Conditions: Pancreatic Cancer

Treatments: Diagnostic Test: SurePathTM

Study type: Observational

Funder types: Other

Identifiers

NCT03606148

1803-094-930

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 2 patient groups

SurePathTM

Description:

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.

Treatment:

Diagnostic Test: SurePathTM

Conventional

Description:

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.

Treatment:

Diagnostic Test: SurePathTM