Contact information
Type
Public
Primary contact
Ms Hannah Stevenson
ORCID ID
Contact details
Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 191 2138429
hannah.stevenson@nuth.nhs.uk
Type
Scientific
Additional contact
Dr Kofi Oppong
ORCID ID
http://orcid.org/0000-0002-7381-7412
Contact details
Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 191 2138429
Kofi.Oppong@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT03532347
Protocol/serial number
33281
Study information
Scientific title
SharkCore biopsy needle versus standard FNA needle in the diagnosis of solid pancreatic masses a randomised controlled cross-over trial of endoscopic ultrasound guided tissue acquisition - The SharkBITE study
Acronym
SharkBITE
Study hypothesis
The aim of this study is to compare the performance of a standard fine needle aspiration needle and the Sharkcore biopsy needle in endoscopic ultrasound guided pancreatic tissue sampling.
Ethics approval
North East - Newcastle & North Tyneside 1 Research Ethics Committee, 08/02/2017, ref: 16/NW/0082
Study design
Randomised; Interventional; Design type: Diagnosis, Device
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs
Intervention
Adult patients with a solid pancreatic mass of any size, requiring EUS guided tissue sampling to make a diagnosis will be eligible to participate. Participants will be randomised to an initial 3 passes with Beacon FNA and then Beacon SharkCore biopsy needles or vice versa. 25g needles will be used for trans duodenal puncture and 22g for transgastric puncture. Randomisation will be via a computer generated list of allocations provided by the statistician to the trial in advance of the study. Whenever a participant is recruited the list will be referred to see what their treatment order is. All procedures will be performed/supervised by expert endosonographers. Samples will be interpreted by 2 separate groups of pathologists. The pathologists reporting the samples will be blinded to the results with the alternative device. Each participant’s involvement in the study will continue for 7 days post procedure to allow for monitoring for adverse events. There will be a telephone call after 7 days to ascertain any post procedure adverse event. Study duration is envisaged as 16 months comprising 10 months recruitment and 6 months follow up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Diagnostic performance of the 2 needle types will be measured by comparing the sensitivity of standard Beacon FNA needle to the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.
Secondary outcome measures
1. Adequacy of the samples obtained as reported by the pathologist utilising a standard methodology
2. The duration of pathologist reporting time
3. Overall costs including device, pathology processing and pathology lab time
Overall trial start date
01/04/2016
Overall trial end date
30/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Planned Sample Size: 108; UK Sample Size: 108
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 108; UK Sample Size: 108
Participant exclusion criteria
1. A greater than 50% cystic component to the pancreatic mass
2. Any contraindication to pancreatic biopsy
3. Patients with a metal biliary stent in situ and target lesion in the head of pancreas
4. Less than 18 years of age
5. Unable and unwilling to give consent
6. Unwilling to undergo additional biopsies
7. Unable to understand English
8. Pregnancy
Recruitment start date
22/05/2017
Recruitment end date
04/05/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
+44 191 282 5959
andrew.johnston@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Covidien plc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medtronic Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal approximately 8 months after overall trial end date.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/11/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list