SurePathTM Liquid-based Cytology and Conventional Smear Cytology in Pancreatic Lesions
NCT ID: NCT03606148
Last Updated: 2019-01-23
Study Results
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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UNKNOWN
170 participants
OBSERVATIONAL
2018-04-17
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Patients suspected of pancreatic cancer from radiological examinations (CT, MR, ultrasound)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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1803-094-930
Identifier Type: -
Identifier Source: org_study_id
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