Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

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Brief Title

Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

Official Title

SharkCore Biopsy Needle Versus Standard FNA Needle in the Diagnosis of Solid Pancreatic Masses a Randomised Controlled Cross-over Trial of EUS Guided Tissue Acquisition - The SharkBITE Study

Brief Summary

      This study compares the diagnostic performance of Endoscopic ultrasound (EUS) guided fine
      needle aspiration and EUS guided core biopsy (SharkCore) in patients with a solid pancreatic
      mass.
    

Detailed Description

      Endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and fine needle biopsy (FNB)
      are the standard methods for obtaining tissue samples from tumours of the pancreas. The
      diagnostic accuracy by strict criteria is around 75-80%. A non diagnostic sample causes delay
      and the need for a repeat procedure. To date no significant difference has been found between
      standard FNA and standard FNB needles. A novel opposing bevel design (SharkCore) needle for
      FNB may provide better diagnostic performance. The aim of this study is to compare the
      performance of a standard needle and the Sharkcore needle. Patients attending for routine
      biopsy of a suspected pancreatic tumour will be invited to participate. All participants will
      have 3 samples taken with each needle. The samples from each needle will be processed and
      reported separately with the pathologists blinded as to the report from the other needle.
      Following the procedure participants will be observed as normal in the recovery area and
      allowed home later. Further study participation is limited to 1 telephone call at 7 days.
      Participants will be asked if they have developed any new symptoms since the procedure and
      whether they have had to seek medical attention for this.The risks of the study procedure are
      the same as those of a non study procedure. Both needle types are in routine use in our unit.
      The study will be performed in the endoscopy unit of the Freeman hospital. The study is
      funded by a grant from Medtronic the company who make the Sharkcore needle. The study is
      planned to recruit 108 participants over 10 months with a further 6 months of follow up. If
      the new needle is found to perform better its routine use will potentially reduce the delay
      experienced by patients as well as the cost incurred by repeat procedures.
    


Study Type

Interventional


Primary Outcome

The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.

Secondary Outcome

 To compare the adequacy of the sample obtained with standard Beacon FNA needle compared with the SharkCore core biopsy needle in the sampling of solid pancreatic mass lesions.

Condition

Pancreas Cancer

Intervention

EUS-FNA needle (Beacon)

Study Arms / Comparison Groups

 EUS tissue sampling
Description:  Device: EUS-FNA needle (Beacon) 3 passes 25g needle from head of pancreas; 22g needle from neck, body and tail
Device:EUS-FNB needle (Beacon Sharkcore) 3 passes 25g needle from head of pancreas; 22g needle from neck, body and tail

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

108

Start Date

May 22, 2017

Completion Date

November 4, 2018

Primary Completion Date

May 4, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients 18 years and above with a solid pancreatic mass of any size, needing to
             Undergo the EUS examination to collect sample for diagnosis will be recruited for the
             study. The definition of a solid pancreatic mass will be based on an ultrasound or a
             CT scan result or based on the findings of a EUS examination done prior.

          -  Patients should have the ability and be willing to give informed consent

        Exclusion Criteria:

          -  Cysts that do not have a significant solid component will be excluded

          -  Any contraindication to pancreatic biopsy.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kofi Oppong, Dr, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03532347

Organization ID

8090


Responsible Party

Sponsor

Study Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborators

 Medtronic

Study Sponsor

Kofi Oppong, Dr, Principal Investigator, Consultant Gastroenterologist


Verification Date

June 2019