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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Diagnostic test: Fine needle aspiration; Diagnostic test: Rapid on-site evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ROSE by endosonographer; Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization	Diagnostic test: Fine needle aspiration; Diagnostic test: Rapid on-site evaluation
Other: non-ROSE; Submitted to fine-needle aspiration.	Diagnostic test: Fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	Minutes	Procedure

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: EUS-FNA; cytopathology; endosonography; sample adequacy; pancreatic solid lesions
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 45073415.3.0000.5257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No