Endoscopic ultrasound guided pancreatic tissue sampling (SharkBITE Study)

ISRCTN ISRCTN10173433
DOI https://doi.org/10.1186/ISRCTN10173433
ClinicalTrials.gov number NCT03532347
Secondary identifying numbers 33281
Submission date
10/04/2017
Registration date
02/05/2017
Last edited
04/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-comparing-2-needles-doctors-use-to-take-a-sample-of-pancreatic-tissue-the-sharkbite-study

Contact information

Ms Hannah Stevenson
Public

Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Phone +44 191 2138429
Email hannah.stevenson@nuth.nhs.uk
Dr Kofi Oppong
Scientific

Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

ORCiD logoORCID ID 0000-0002-7381-7412
Phone +44 191 2138429
Email Kofi.Oppong@nuth.nhs.uk

Study information

Study designRandomised; Interventional; Design type: Diagnosis, Device
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSharkCore 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
Study acronymSharkBITE
Study objectivesThe 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(s)North East - Newcastle & North Tyneside 1 Research Ethics Committee, 08/02/2017, ref: 16/NW/0082
Health condition(s) or problem(s) studiedSpecialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs
InterventionAdult 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 typeOther
Primary outcome measureDiagnostic 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 measures1. 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 study start date01/04/2016
Completion date30/11/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 108; UK Sample Size: 108
Key inclusion criteriaPlanned Sample Size: 108; UK Sample Size: 108
Key exclusion criteria1. 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
Date of first enrolment22/05/2017
Date of final enrolment04/05/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre

Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
England
United Kingdom

Phone +44 191 282 5959
Email andrew.johnston@nuth.nhs.uk
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Industry

Covidien plc

No information available

Medtronic Ltd

No information available

Results and Publications

Intention to publish date30/11/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal approximately 8 months after overall trial end date.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

04/07/2019: ClinicalTrials.gov number added.
17/07/2018: The following changes were made to the trial record:
1. The trial end date was changed from 30/09/2018 to 30/11/2018
2. The recruitment end date was changed from 30/03/2018 to 04/05/2018
3. The intention to publish date was changed from 31/01/2019 to 30/11/2019
22/01/18: The following changes were made:
1. Recruitment end date was changed from 01/12/2017 to 30/03/2018.
2. Overall trial end date was changed from 01/05/2018 to 30/09/2018.
16/01/2018: Cancer Help UK lay summary link added to plain English summary field.
16/10/2017: Internal review.
15/09/2017: Internal review.
06/06/2017: Internal review.
09/05/2017: Verified study information with principal investigator.