The Use of a New Core Needle in the Endoscopic Ultrasound Assisted Tissue Sampling for Pancreatic Solid Masses

Istituto Clinico Humanitas100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Pancreatic Masses

Interventions

FNA with 25 G Beacon needleDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy

Outcomes

Primary Outcomes

Core acquisition

The presence of a core adequate for histological evaluation for final diagnosis

Time frame: 24 h

Data from ClinicalTrials.gov

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