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OpenTrials
Completed

NCT Number: NCT02946840

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FNA with 25 G Beacon needle

Device

Primary outcomes

  1. Core acquisition

    Time frame: 24 h

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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona
  • Azienda Unità Sanitaria Locale di Imola
  • Catholic University of the Sacred Heart
  • Maggiore Bellaria Hospital, Bologna
  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 27, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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