NCT Number: NCT04002778
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Rapid on-site evaluation
Diagnostic TestPrimary outcomes
-
Procedure duration
Time frame: Procedure
Minutes
Secondary outcomes
-
Specimen adequacy rate
Time frame: Through study completion, an average of 18 months
Cases with a sample suitable for a definitive diagnosis over the total number of cases
-
Total number of passes
Time frame: Through study completion, an average of 18 months
total number of passes of all procedures
-
Number of adverse events
Time frame: Through study completion, an average of 18 months
Total number of adverse events of all procedures
-
Diagnostic yield
Time frame: Through study completion, an average of 18 months
Cases in which a final diagnostic could be established over the total number of cases
Sponsors and collaborators
Lead sponsor
Universidade Federal do Rio de Janeiro
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jul 1, 2019
- Registry last updated
- Jul 1, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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