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

Completed

• Conditions: Pancreatic Masses
• Interventions: Device: FNA with 25 G Beacon needle

• Registration Number: NCT02946840
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-27
• Primary Completion: 2017-05
• Study Completion: 2018-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid pancreatic masses	FNA with 25 G Beacon needle	Consecutive patients with solid pancreatic masses, submitted to FNA with 25 G Beacon needle (Medtronic, Newton, MA, USA)

Primary Outcome Measures

Name	Time	Method
Core acquisition	24 h	The presence of a core adequate for histological evaluation for final diagnosis

Trial Locations

Locations (1)

Endoscopy Unit, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy