Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions

NACompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

February 14, 2018

Primary Completion Date

December 15, 2019

Study Completion Date

December 15, 2019

Conditions
Solid Pancreatic Tumor
Interventions
PROCEDURE

EUS

Radial endoscopic ultrasound. A special endoscope uses high-frequency sound waves to produce detailed images of the lining and walls of the digestive tract , and allows to take samples from abnormal areas.

PROCEDURE

FNA with ROSE

Endoscopic ultrasound guided biopsy of the pancreas with the traditional fine needle aspirate needle with the addition of rapid on-site cytopathology (cytopathologist looking at each biopsy samples as they are taken): The sampling is done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed.

PROCEDURE

FNB alone

Endoscopic ultrasound guided biopsy with a novel core biopsy needle without on-site cytopathology: New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology).

Trial Locations (6)

Unknown

University of Alberta, Edmonton

Vancouver General Hospital, Vancouver

Moncton Hospital, Moncton

The Ottawa Hospital, Ottawa

H2V 2Y4

Jewish General Hospital, Montreal

H3G 1A4

McGill University Health Centre, Montreal

All Listed Sponsors
lead

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

NCT03435588 - Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions | Biotech Hunter | Biotech Hunter