Trials / Terminated
TerminatedNCT05394129
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
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 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. |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2022-01-31
- Completion
- 2023-01-30
- First posted
- 2022-05-27
- Last updated
- 2024-11-29
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05394129. Inclusion in this directory is not an endorsement.