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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TERMINATED
89 participants
OBSERVATIONAL
2019-04-09
2023-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SurePath™
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.
SurePath™
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.
Conventional
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.
SurePath™
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.
Interventions
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SurePath™
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.
Eligibility Criteria
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Inclusion Criteria
* Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.
Exclusion Criteria
* Patients younger than 19 years of age
* Serious mental patients
* Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
* 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
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Soo-Jeong Cho
Clinical associate professor
Principal Investigators
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Han Myung Lee, M.D.
Role: STUDY_DIRECTOR
Fellowship
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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1902-076-1011
Identifier Type: -
Identifier Source: org_study_id