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

Fine needle aspiration

Rapid on-site evaluation

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.

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.

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

Cases with a sample suitable for a definitive diagnosis over the total number of cases

Total number of adverse events of all procedures

Cases in which a final diagnostic could be established over the total number of cases

Universidade Federal do Rio de Janeiro

Associate Professor, Internal Medicine

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Standard technique EUS-FNA

Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Capillary suction technique for EUS FNA

Mouen A Khashab, MD

The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.

There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided

Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

Sensitivity of the EUS-FNA with Capillary technique

Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions

The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass

The rate of acquiring core tissue of the pancreatic mass through EUS-FNA

The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease

Boston Scientific Corporation

Johns Hopkins University

Assistant Professor of Medicine; Director of Therapeutic Endoscopy

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Suction Technique

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Capillary Technique

Total

Age, Continuous

Sex: Female, Male

Chronic Pancreatitis

Chemotherapy

Radiation therapy

Prior History

Prior non-diagnostic FNA

Antiplatelet therapy

Uncinate/Head

Neck

Body

Tail

Pancreatic mass Location

Pancreatic mass size

Hypoecho

Isoecho

Hyperecho

Echogeicity of the lesion

Cystic Component

Arterial

Venous

Arterial and Venous

Vascular involvement

EUS features of chronic pancreatitis

Metal stent

Plastic stent

Number of patients having biliary stent at the time of EUS-FNA

Biliary stent present

The endosonographers were not blinded to the procedure technique. A small possibility that cytotechnicians may have witnessed the technique. Cellularity of the specimens were not quantified. A 6 months follow-up may not detect all false negatives

Dr. Mouen Khashab

Diagnostic Yield of Capillary Technique

Standard Technique

Diagnostic Yield of Standard Technique

Positive EUS-FNA

Negative EUS-FNA

gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.

Patients With Positive Gold Standard

Patients With Negative Gold Standard

The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?	NCT04002778	Pancreatic Neop...	Fine needle asp... Rapid on-site e...	18 Years -	Universidade Federal do Rio de Janeiro
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions	NCT01936467	Pancreatic Soli... Pancreatic Mass	Standard techni... Capillary sucti...	18 Years - 90 Years	Johns Hopkins University
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions	NCT01936467	Pancreatic Soli... Pancreatic Mass	Standard techni... Capillary sucti...	18 Years - 90 Years	Johns Hopkins University

Spots Global Cancer Trial Database for pancreatic solid lesions