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

NCT02946840 | Completed DMC

• 1 other identifier: Studio 1587
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Masses

Outcome Measures

Primary Outcomes (1)

• Core acquisition

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

  24 h

Study Arms (1)

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

Interventions

FNA with 25 G Beacon needle DEVICE

Solid pancreatic masses

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 31010744 DERIVED

Study Officials

• Alessandro Repici, MD

  Humanitas University

  STUDY DIRECTOR

• Silvia Carrara, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

• Alberto Larghi, MD

  Università Cattolica

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: October 27, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)