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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.
Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSE by endosonographer | Active Comparator | Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization |
|
| non-ROSE | Other | Submitted to fine-needle aspiration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fine needle aspiration | Diagnostic Test |
| ||
| Rapid on-site evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Minutes | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Specimen adequacy rate | Cases with a sample suitable for a definitive diagnosis over the total number of cases | Through study completion, an average of 18 months |
| Total number of passes | total number of passes of all procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
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| Diagnostic Test |
|
| Through study completion, an average of 18 months |
| Number of adverse events | Total number of adverse events of all procedures | Through study completion, an average of 18 months |
| Diagnostic yield | Cases in which a final diagnostic could be established over the total number of cases | Through study completion, an average of 18 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |