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

NCT03322592 | Completed FDA Device

• 1 other identifier: 1481CESC
• Study Type: interventional
• Target: 800
• Locations: 8 countries
• Sites: 13

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.

Conditions

Biopsy, Fine-needle; Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Procurement yield of tissue "core"

  6 months

• Samples tissue integrity

  6 months

• Samples blood contamination

  6 months

• Time (minutes) of the procedures with and without ROSE

  6 months

• Percentage of procedure related adverse events [Safety]

  6 months

Study Arms (2)

EUS-FNB with ROSE

ACTIVE COMPARATOR

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)

EUS-FNB without ROSE

ACTIVE COMPARATOR

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

Interventions

Rapid on-site evaluation (ROSE) DIAGNOSTIC_TEST

On-site evaluation of the acquired samples will be performed by pathologist

EUS-FNB with ROSE

Histologic evaluation DIAGNOSTIC_TEST

Samples collected in the EUS-FNB without ROSE will be processed as histologic samples

EUS-FNB without ROSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Pregnancy

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (13)

University of Virginia Health Sciences Center

Charlottesville, Virginia, 22901, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Cliniques Universitaires St-Luc

Brussels, Belgium

Location

Istituto Humanitas

Milan, Italy

Location

ISMETT

Palermo, Italy

Location

Ospedale Civico

Palermo, Italy

Location

Azienda Ospedaliera Integrata Verona

Verona, 37134, Italy

Location

Tokyo Medical University Hospital

Tokyo, Japan

Location

Wakayama Medical University School of Medicine

Wakayama, Japan

Location

Erasmus MC

Rotterdam, Netherlands

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Clinico Univarsitario de Santiago

Santiago de Compostela, Spain

Location

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34116031 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Stefano Francesco Crinò, MD

  Azienda Ospedaliera Integrata Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 26, 2017
• Study Start: March 29, 2018
• Primary Completion: December 13, 2019
• Study Completion: July 30, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

IT (4); AU (1); US (1); NL (1); BE (1); SE (1); ES (2); JP (2)