EUS guided pancreatic tissue sampling (SharkBITE Study)
Research type
Research Study
Full 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
IRAS ID
212701
Contact name
Kofi ENW Oppong
Contact email
Sponsor organisation
The Newcastle upon Tyne NHS Foundation Trust
Duration of Study in the UK
1 years, 3 months, days
Research summary
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 to check if the participants have had an adverse event. 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.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0019
Date of REC Opinion
8 Feb 2017
REC opinion
Further Information Favourable Opinion