Clinical trial NCT02946840: The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses
Official title: The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Masses
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Maggiore Bellaria Hospital, Bologna
name: Catholic University of the Sacred Heart
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Azienda Unità Sanitaria Locale di Imola
First posted: 2016-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients referred for EUS examination and FNA of solid pancreatic masses, will undergo EUS-FNA with the 25G Shark core needle.

Brief summary: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from pancreatic masses. A new core biopsy needle has been developed by Beacon bnx® (Medtronic, Newton, MA) that allows the possibility to achieve a core for histology evaluation and the interchangibility of needle size using the same needle shelter and different needle sizes.

Detailed description: At every pass, the material will be fixed in formalin. Three passes will be done. Details of the aspirated material will be described at macroscopic evaluation by the endoscopist and then by the pathologist at macroscopic and microscopic evaluation, in order to find an interobserved agreement on the definition of the core.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 and less than 90, both genders..
* Presence of a pancreatic solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
* Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma or coagulation factors.
* Informed consent is obtained.

Exclusion Criteria:

* Previous biopsy of the lesion with diagnosis of malignancy
* Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
* Pregnancy or breast-feeding.
* Patients unable to understand and/or read the consent form.

Primary outcomes:
measure: Core acquisition
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
affiliation: Humanitas University
name: Alessandro Repici, MD
role: STUDY_DIRECTOR
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Silvia Carrara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università Cattolica
name: Alberto Larghi, MD
role: STUDY_DIRECTOR
References:
citation: Di Leo M, Crino SF, Bernardoni L, Rahal D, Auriemma F, Correale L, Donato G, Massidda M, Anderloni A, Manfrin E, Armellini E, Poliani L, Fugazza A, Semeraro R, Occhipinti P, Repici A, Carrara S. EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study. Dig Liver Dis. 2019 Sep;51(9):1275-1280. doi: 10.1016/j.dld.2019.03.025. Epub 2019 Apr 20.