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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Masses
• Intervention / Treatment: Device: FNA with 25 G Beacon needle

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Endoscopy Unit, Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Solid pancreatic masses; Consecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA)	Device: FNA with 25 G Beacon needle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona; Catholic University of the Sacred Heart; Maggiore Bellaria Hospital, Bologna; The Mediterranean Institute for Transplantation and Advanced Specialized Therapies; Azienda Unità Sanitaria Locale di Imola
• Investigators: Study Director: Alessandro Repici, MD, Humanitas University; Principal Investigator: Silvia Carrara, MD, Humanitas Hospital; Study Director: Alberto Larghi, MD, Università Cattolica

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Studio 1587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO