Clinical trial · Observational
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
NCT05394129CI-TRIAL-00083140terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruiting research subjects
Summary
Brief summary (as posted)
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Submucosal Tumor of Gastrointestinal Tract | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SurePath™ | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SurePath™
- description
- 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.
- interventionNames
- Diagnostic Test: SurePath™
- label
- Conventional
- description
- 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.
- interventionNames
- Diagnostic Test: SurePath™
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- 6 months after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who signed the agreement after the explanation * Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations. Exclusion Criteria: * Those who did not agree with the study * 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
References
Publications (0)
Data not yet available
No reference posted for this study.