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

Pancreatic Masses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946840
• Other study ID #: Studio 1587
• Status: Completed
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Masses

Intervention

Device:
• FNA with 25 G Beacon needle

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (6)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Azienda Ospedaliera Universitaria Integrata Verona, Azienda Unità Sanitaria Locale Imola, Catholic University of the Sacred Heart, Maggiore Bellaria Hospital, Bologna, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Country where clinical trial is conducted

Italy, 

Outcome

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