Clinical trial NCT04002778: Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
Official title: Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Keywords: EUS-FNA
pancreatic solid lesions
sample adequacy
cytopathology
endosonography
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure duration
timeFrame: Procedure
Secondary outcomes:
measure: Specimen adequacy rate
timeFrame: Through study completion, an average of 18 months
measure: Total number of passes
timeFrame: Through study completion, an average of 18 months
measure: Number of adverse events
timeFrame: Through study completion, an average of 18 months
measure: Diagnostic yield
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
Study officials:
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