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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03322592
Registration number
NCT03322592
Ethics application status
Date submitted
19/10/2017
Date registered
26/10/2017
Date last updated
30/09/2020
Titles & IDs
Public title
EUS-FNB With ROSE Vs. EUS-FNB Without ROSE
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Scientific title
A Multicenter Randomized Trial, Comparing EUS Fine Needle Biopsy (EUS-FNB) With Rapid On-Site Evaluation (ROSE) Versus EUS-FNB Alone for the Evaluation of Patients With Solid Pancreatic Lesions
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Secondary ID [1]
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1481CESC
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Universal Trial Number (UTN)
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Trial acronym
FROSENOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biopsy, Fine-needle
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Pancreatic Neoplasm
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Rapid on-site evaluation (ROSE)
Diagnosis / Prognosis - Histologic evaluation
Active comparator: EUS-FNB with ROSE - Intervention: Rapid on-site evaluation (ROSE) In the EUS-FNB with ROSE arm, the material obtained with the first pass will be processed for ROSE using the touch imprint technique. The biopsy specimen is carefully pressed onto the slide, allowing the superficial cells to adhere, and then gently lifted with forceps thereby creating a touch imprint of the specimen on the slide. In case of inadequate sample, a second pass will be done and the touch imprint technique will be repeated up to a maximum of 3 passes. In case of adequate ROSE at the first or the second pass, the additional passes will be performed as EUS-FNB and the material obtained placed directly into formalin or other fixative for subsequent histopathological evaluation.
Active comparator: EUS-FNB without ROSE - Intervention: histologic evaluation In the FNB alone arm, 3 needle passes will be performed and the samples obtained will be placed directly in a vial containing formalin (or other fixative according to the local individual protocol). Macroscopic on-site evaluation (MOSE) of acquired sample will be then performed by the endoscopist.
Diagnosis / Prognosis: Rapid on-site evaluation (ROSE)
On-site evaluation of the acquired samples will be performed by pathologist
Diagnosis / Prognosis: Histologic evaluation
Samples collected in the EUS-FNB without ROSE will be processed as histologic samples
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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EUS-FNB diagnostic accuracy
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Assessment method [1]
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Defined as the ratio between the sum of true positive and true negative values divided by the number of lesions.
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Procurement yield of tissue "core"
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Assessment method [1]
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Procurement percentage of a "core" (defined as a piece of tissue at least 550 micron in the greatest axis) in the two arms and using three different needles types.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Samples tissue integrity
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Assessment method [2]
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Tissue integrity will be evaluated by attributing a score from zero to 6 (6 represents the better outcome), according to the following score system:
0=Insufficient material for interpretation. 1=Sufficient material for limited cytological interpretation; probably not representative. 2=Sufficient material for adequate cytological interpretation. 3=Sufficient material for low quality histological interpretation (microfragments \< 550 micron in greatest axis). 4=Sufficient material for good quality histological interpretation (1 to 5 cores \> 550 micron in greatest axis). 5=Sufficient material for high quality histological interpretation (6 to 10 cores \> 550 micron in greatest axis). 6=Sufficient material for excellent quality histological interpretation (more than 10 cores \> 550 micron in greatest axis or total tissue length \> 5.500 micron).
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Samples blood contamination
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Assessment method [3]
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Blood contamination will be evaluated by attributing a score from zero to 3 (3 represents the better outcome), according to the following score system:
0=Only blood. 1=Much blood contamination, surface area \> 50 % of the slide. 2=Medium blood contamination, surface area 25-50 % of the slide. 3=Little blood contamination, surface area \< 25 % of slide.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Time (minutes) of the procedures with and without ROSE
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Assessment method [4]
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Time of the procedure is defined by the time from the insertion of the needle into the working channel of the echoendoscope for the first pass to the removal of the needle after the third pass
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Percentage of procedure related adverse events [Safety]
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Assessment method [5]
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Intra-procedural and post-procedural adverse events in the 2 arms and using three different needle types will be evaluated
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Macroscopic on-site evaluation [MOSE]
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Assessment method [6]
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Concordance between presence of a core at Macroscopic on-site evaluation (MOSE) and presence of core at histopathological evaluation, in the EUS-FNB without ROSE arm.
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Timepoint [6]
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6 months
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Eligibility
Key inclusion criteria
* Solid pancreatic mass referred for EUS-guided tissue acquisition
* Lesion can be visualized with EUS and needle puncturing can be technically feasible
* Written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of anticoagulants that cannot be discontinued
* International Normalized Ratio (INR) >1.5 or platelet count <50.000
* Cystic lesions even with solid component
* Previous inclusion in other or present study
* Pregnancy
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/07/2020
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Sample size
Target
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Accrual to date
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Final
800
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Virginia
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Belgium
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Brussels
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Italy
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Milano
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Italy
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Palermo
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Italy
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Verona
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Japan
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State/province [6]
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Tokyo
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Country [7]
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Japan
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State/province [7]
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Wakayama
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Country [8]
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Netherlands
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Rotterdam
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Country [9]
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Spain
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State/province [9]
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Barcellona
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Country [10]
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Spain
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State/province [10]
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Santiago De Compostela
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Country [11]
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Sweden
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State/province [11]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Other
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Name
Azienda Ospedaliera Universitaria Integrata Verona
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Rationale: Rapid on-Site Evaluation (ROSE) of cytologic specimens acquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Cytologic interpretation, however, requires a high degree of expertise rarely found outside high volume centers and ROSE is not available in many countries. This has created a barrier to the widespread dissemination of EUS in the community and throughout the world, because the lack of cytologic expertise has resulted in a low diagnostic accuracy and, therefore, in a limited perceived utility of EUS. A device that is able to: (i) acquire histologic core biopsy samples usually easier to be interpreted; (ii) be used by most of the endosonographers and not only by the experts; (iii) have a performance at least not inferior to ROSE, will represent a major breakthrough in the field of EUS tissue acquisition. The availability of such needles will determine a shift from cytology to histology that will overcome some of the limitations of cytology and ROSE, thus strongly contributing to the diffusion of EUS throughout the world and in the community. Objectives: To compare the performance and the diagnostic accuracy of EUS-guided fine needle biopsy (EUS-FNB) coupled with ROSE with that of EUS-FNB alone using an FNB needle. Study design: International randomized multicenter trial. Study population: Patients =18 years old, referred for EUS-guided tissue sampling of a solid pancreatic mass. Intervention: EUS-guided tissue acquisition by means of either EUS-FNB with ROSE or EUS-FNB alone, using one of the following FNB needles: Procore 20-gauge, SharkCore 22-gauge or Acquire 22-gauge. Main study parameters/endpoints: The main endpoint is the diagnostic accuracy, measured against the gold standard diagnosis that will be surgical resection specimen or in non-operated patients the results of other diagnostic work-up (other tissue sampling techniques and imaging studies) or the clinical course of the disease. Secondary endpoints include: i) safety; ii) presence of tissue core; iii) feasibility to perform additional immunohistochemical/molecular biology analyses; iv) time of the sampling procedure.
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Trial website
https://clinicaltrials.gov/study/NCT03322592
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Trial related presentations / publications
Crino SF, Di Mitri R, Nguyen NQ, Tarantino I, de Nucci G, Deprez PH, Carrara S, Kitano M, Shami VM, Fernandez-Esparrach G, Poley JW, Baldaque-Silva F, Itoi T, Manfrin E, Bernardoni L, Gabbrielli A, Conte E, Unti E, Naidu J, Ruszkiewicz A, Amata M, Liotta R, Manes G, Di Nuovo F, Borbath I, Komuta M, Lamonaca L, Rahal D, Hatamaru K, Itonaga M, Rizzatti G, Costamagna G, Inzani F, Curatolo M, Strand DS, Wang AY, Gines A, Sendino O, Signoretti M, van Driel LMJW, Dolapcsiev K, Matsunami Y, van der Merwe S, van Malenstein H, Locatelli F, Correale L, Scarpa A, Larghi A. Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial. Gastroenterology. 2021 Sep;161(3):899-909.e5. doi: 10.1053/j.gastro.2021.06.005. Epub 2021 Jun 9.
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Public notes
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Contacts
Principal investigator
Name
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Stefano Francesco Crinò, MD
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Address
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Azienda Ospedaliera Integrata Verona
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Fax
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03322592
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