Clinical trial 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
Official title: 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: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Pancreatic Tumor
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Procedures are performed with a linear echoendoscope under conscious sedation. EUS-FNB is performed with a 22G or 25G needles Core-needle. Tissue sampling technique is standardized between the endoscopists. Two passes are performed using the core needle. A third pass is allowed if, on macroscopic inspection of the acquired sample, the specimen is deemed insufficient by the endoscopist. EUS-FNA with ROSE is performed with a 22 or 25 gauge FNA needle.

This is a multi-center, randomized, single blinded, non-inferiority, trial comparing EUS-FNB alone to EUS-FNA with ROSE in the diagnosis of solid pancreatic masses. Following consent, patients are randomized, at the time of the procedure, to undergo either EUS-FNB alone or EUS-FNA with ROSE. The randomization sequence will be generated by a computerized randomization scheme using a block size of 10 stratified according to the endoscopist.
Primary purpose: DIAGNOSTIC

Brief summary: Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. This is done by inserting a small camera (endoscope) through the mouth of the patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas can be acquired through the stomach. The sampling is usually 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 immediately under the microscope and can give feedback to the endoscopist until enough cells has been acquired for a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer but is expensive and requires significant amount of resources. 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) and has been shown to be also very accurate in the diagnosis of pancreatic cancer.

The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional needle (FNA) with the help of an immediate assessment of the obtained samples under the microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear which one is superior. This is a randomized trial meaning that the participants would either undergo biopsy with the new needle or with the traditional needle plus the addition of on-site assessment of the obtained samples. The advantage of the new needle is that it is easy to implement and likely much cheaper. If the investigators can show in our study that the new needles are as accurate as FNA with ROSE then FNB could be implemented across hospitals worldwide in an easier and less expensive fashion.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients referred for EUS evaluation of a definite solid pancreatic mass noted on computed tomography(CT)/Magnetic resonance imaging(MRI)/EUS, in which malignancy is suspected with no previous histological diagnosis

Exclusion Criteria:

* Age \< 18 years, pregnant patients.
* Uncorrectable coagulopathy Prothrombin time (PT) \>50% of control, Partial Thromboplastin time (PTT) \>50 sec, or International normalized ratio (INR) \>1.5 and/or uncorrectable thrombocytopenia platelet count\<50, 000109/L.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 12 months
measure: Final diagnosis of malignant pancreatic mass
timeFrame: 10 months
measure: Final diagnosis of benign pancreatic mass
timeFrame: 10 months
Secondary outcomes:
measure: Diagnostic characteristics
timeFrame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
measure: Specimen adequacy
timeFrame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
measure: Median number of needle passes
timeFrame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
measure: Procedural time
timeFrame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
measure: Rate of procedure-related adverse events
timeFrame: 6 to 12 months of data collection and 3 to 6 months of data analysis.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Yen-I Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
citation: Kulesza P, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration: sampling, pitfalls, and quality management. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1248-54. doi: 10.1016/j.cgh.2007.09.011.
citation: Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034-1039. doi: 10.1016/j.gie.2016.03.1405. Epub 2016 Mar 24.
citation: Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
citation: Chen YI, Chatterjee A, Berger R, Kanber Y, Wyse J, Lam E, Gan I, Auger M, Kenshil S, Telford J, Donnellan F, Quinlan J, Lutzak G, Alshamsi F, Parent J, Waschke K, Alghamdi A, Barkun J, Metrakos P, Chaudhury P, Martel M, Dorreen A, Candido K, Miller C, Adam V, Barkun A, Zogopoulos G, Wong C. Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial. Endoscopy. 2022 Jan;54(1):4-12. doi: 10.1055/a-1375-9775. Epub 2021 Apr 15.