Clinical trial · Interventional
Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
NCT04002778CI-TRIAL-00039281completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.
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 Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine needle aspiration | Diagnostic Test | — | UNRESOLVED |
| Rapid on-site evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ROSE by endosonographer
- description
- Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization
- interventionNames
- Diagnostic Test: Fine needle aspiration
- Diagnostic Test: Rapid on-site evaluation
- type
- OTHER
- label
- non-ROSE
- description
- Submitted to fine-needle aspiration.
- interventionNames
- Diagnostic Test: Fine needle aspiration
Primary outcomes (1)
- measure
- Procedure duration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI). * formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy. Exclusion Criteria: * a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods * lesions previously punctured on past EUS-FNA procedures * American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V * cases of surveillance of solid pancreatic lesions * severe coagulation disorder (platelet count \< 50000 or International Normalized Ratio \> 2,0) * impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all) * patient unwillingness to participate
References
Publications (0)
Data not yet available
No reference posted for this study.