Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Pancreatic Neoplasms Clinical Trial

Official title: Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pancreatic Neoplasms

• NCT number: NCT04002778
• Study type: Interventional
• Source: Universidade Federal do Rio de Janeiro
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: March 2017