EUS-FNB With ROSE Vs. EUS-FNB Without ROSE

Completed · Not applicable

Conditions studied: Biopsy, Fine-needle, Pancreatic Neoplasm

In brief

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.

Key facts

Study ID: NCT03322592
Run by: Azienda Ospedaliera Universitaria Integrata Verona
People needed: 800
Starts: 2018-03-29
Expected to finish: 2020-07-30
Last updated by the study team: 2020-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Virginia Health Sciences Center — Charlottesville, Virginia, United States
Royal Adelaide Hospital — Adelaide, Australia
Cliniques Universitaires St-Luc — Brussels, Belgium
Istituto Humanitas — Milan, Italy
ISMETT — Palermo, Italy
Ospedale Civico — Palermo, Italy
Azienda Ospedaliera Integrata Verona — Verona, Italy
Tokyo Medical University Hospital — Tokyo, Japan
Wakayama Medical University School of Medicine — Wakayama, Japan
Erasmus MC — Rotterdam, Netherlands
Hospital Clinic — Barcelona, Spain
Hospital Clinico Univarsitario de Santiago — Santiago de Compostela, Spain
Karolinska Institutet — Stockholm, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.