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

NCT ID: NCT04002778

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-31

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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ROSE by endosonographer

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

Group Type: ACTIVE_COMPARATOR

Fine needle aspiration

Intervention Type: DIAGNOSTIC_TEST

Rapid on-site evaluation

Intervention Type: DIAGNOSTIC_TEST

non-ROSE

Submitted to fine-needle aspiration.

Group Type: OTHER

Fine needle aspiration

Intervention Type: DIAGNOSTIC_TEST

Interventions

Fine needle aspiration

Intervention Type: DIAGNOSTIC_TEST

Rapid on-site evaluation

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Rezende

Associate Professor, Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

45073415.3.0000.5257

Identifier Type: -

Identifier Source: org_study_id