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

NCT ID: NCT03606148

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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 sample.

SurePathTM

Intervention Type DIAGNOSTIC_TEST

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.

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 second obtained sample.

SurePathTM

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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SurePathTM

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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Hyub Lee, MD. PhD.

Role: CONTACT

+82-2-2072-4892

Min su You, MD

Role: CONTACT

+82-2-2072-3168

Facility Contacts

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Sang Hyub Lee, MD. PhD

Role: primary

+82-2-2072-4892

References

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Chun JW, Lee K, Lee SH, Kim H, You MS, Hwang YJ, Paik WH, Ryu JK, Kim YT. Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study. Gastrointest Endosc. 2020 Apr;91(4):837-846.e1. doi: 10.1016/j.gie.2019.11.018. Epub 2019 Nov 20.

Reference Type DERIVED
PMID: 31759036 (View on PubMed)

Other Identifiers

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1803-094-930

Identifier Type: -

Identifier Source: org_study_id

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