Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
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.
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.
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.