Clinical trial · Observational
Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation
Prospective Evaluation of the Yield and Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy in the Absence of Rapid Onsite Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
\<Background/aims\> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies across EUS programs in Unites States, Europe and other areas of world. The investigators have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in which the adequacy of specimens will be assessed by a single endosonographer. \<Methods\> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-FNA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EUS-FNA
- description
- Any patients who will undergo EUS-FNA for pancreas lesion during the study period
- interventionNames
- Procedure: EUS-FNA
Primary outcomes (1)
- measure
- Sensitivity, specificity and accuracy of EUS-FNA without ROSE
- timeFrame
- 7 days
- description
- Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of EUS-FNA without ROSE
Secondary outcomes (1)
- measure
- Adequacy of obtained cytologic specimens
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion Exclusion Criteria: * Patients who refuse to undergo EUS-FNA
References
Publications (0)
Data not yet available