Pancreatic Neoplasm Clinical Trial
— FROSENOROfficial 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
NCT number | NCT03322592 |
Other study ID # | 1481CESC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 29, 2018 |
Est. completion date | July 30, 2020 |
Verified date | September 2020 |
Source | Azienda Ospedaliera Universitaria Integrata Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 800 |
Est. completion date | July 30, 2020 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Belgium | Cliniques Universitaires St-Luc | Brussels | |
Italy | Istituto Humanitas | Milano | |
Italy | ISMETT | Palermo | |
Italy | Ospedale Civico | Palermo | |
Italy | Azienda Ospedaliera Integrata Verona | Verona | |
Japan | Tokyo Medical University Hospital | Tokyo | |
Japan | Wakayama Medical University School of Medicine | Wakayama | |
Netherlands | Erasmus MC | Rotterdam | |
Spain | Hospital Clinic | Barcellona | |
Spain | Hospital Clinico Univarsitario de Santiago | Santiago De Compostela | |
Sweden | Karolinska Institutet | Stockholm | |
United States | University of Virginia Health Sciences Center | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona |
United States, Australia, Belgium, Italy, Japan, Netherlands, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EUS-FNB diagnostic accuracy | Defined as the ratio between the sum of true positive and true negative values divided by the number of lesions. | 6 months | |
Secondary | Procurement yield of tissue "core" | 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. | 6 months | |
Secondary | Samples tissue integrity | 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). |
6 months | |
Secondary | Samples blood contamination | 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. |
6 months | |
Secondary | Time (minutes) of the procedures with and without ROSE | 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 | 6 months | |
Secondary | Percentage of procedure related adverse events [Safety] | Intra-procedural and post-procedural adverse events in the 2 arms and using three different needle types will be evaluated | 6 months | |
Secondary | Macroscopic on-site evaluation [MOSE] | 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. | 6 months |
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