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

Universidade Federal do Rio de Janeiro

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Diagnostic Test: Rapid on-site evaluation; Diagnostic Test: Fine needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT04002778

45073415.3.0000.5257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

ROSE by endosonographer

Active Comparator group

Description:

Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization

Treatment:

Diagnostic Test: Rapid on-site evaluation

Diagnostic Test: Fine needle aspiration

non-ROSE

Other group

Description:

Submitted to fine-needle aspiration.

Treatment:

Diagnostic Test: Fine needle aspiration