Endoscopic ultrasound guided pancreatic tissue sampling (SharkBITE Study)
| ISRCTN | ISRCTN10173433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10173433 |
| ClinicalTrials.gov (NCT) | NCT03532347 |
| Protocol serial number | 33281 |
| Sponsor | The Newcastle Upon Tyne Hospitals NHS Foundation Trust |
| Funders | Covidien plc, Medtronic Ltd |
- 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| hannah.stevenson@nuth.nhs.uk |
Scientific
Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0002-7381-7412 |
|---|---|
| Phone | +44 191 2138429 |
| Kofi.Oppong@nuth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Diagnosis, Device |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | SharkBITE |
| Study objectives | 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(s) | North East - Newcastle & North Tyneside 1 Research Ethics Committee, 08/02/2017, ref: 16/NW/0082 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Adequacy of the samples obtained as reported by the pathologist utilising a standard methodology |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 108 |
| Key inclusion criteria | Planned Sample Size: 108; UK Sample Size: 108 |
| Key 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 |
| Date of first enrolment | 22/05/2017 |
| Date of final enrolment | 04/05/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
