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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02946840

Enrollment

100

Registered

2016-10-27

Start date

2016-08-31

Completion date

2018-05-31

Last updated

2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Masses

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.

Interventions

DEVICEFNA with 25 G Beacon needle

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Core acquisition	24 h	The presence of a core adequate for histological evaluation for final diagnosis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026