EUS-FNB With ROSE Vs. EUS-FNB Without ROSE (FROSENOR)
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|ClinicalTrials.gov Identifier: NCT03322592|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2017
Last Update Posted : December 17, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Biopsy, Fine-needle Pancreatic Neoplasm||Diagnostic Test: Rapid on-site evaluation (ROSE) Diagnostic Test: Histologic evaluation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||March 29, 2018|
|Actual Primary Completion Date :||December 13, 2019|
|Estimated Study Completion Date :||July 30, 2020|
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.
Diagnostic Test: Rapid on-site evaluation (ROSE)
On-site evaluation of the acquired samples will be performed by pathologist
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.
Diagnostic Test: Histologic evaluation
Samples collected in the EUS-FNB without ROSE will be processed as histologic samples
- EUS-FNB diagnostic accuracy [ Time Frame: 6 months ]Defined as the ratio between the sum of true positive and true negative values divided by the number of lesions.
- Procurement yield of tissue "core" [ Time Frame: 6 months ]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.
- Samples tissue integrity [ Time Frame: 6 months ]
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).
- Samples blood contamination [ Time Frame: 6 months ]
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.
- Time (minutes) of the procedures with and without ROSE [ Time Frame: 6 months ]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
- Percentage of procedure related adverse events [Safety] [ Time Frame: 6 months ]Intra-procedural and post-procedural adverse events in the 2 arms and using three different needle types will be evaluated
- Macroscopic on-site evaluation [MOSE] [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322592
|United States, Virginia|
|University of Virginia Health Sciences Center|
|Charlottesville, Virginia, United States, 22901|
|Royal Adelaide Hospital|
|Cliniques Universitaires St-Luc|
|Azienda Ospedaliera Integrata Verona|
|Verona, Italy, 37134|
|Tokyo Medical University Hospital|
|Wakayama Medical University School of Medicine|
|Hospital Clinico Univarsitario de Santiago|
|Santiago De Compostela, Spain|
|Principal Investigator:||Stefano Francesco Crinò, MD||Azienda Ospedaliera Integrata Verona|