Condition category
Cancer
Date applied
10/04/2017
Date assigned
02/05/2017
Last edited
15/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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

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 measures

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

01/05/2018

Reason abandoned

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

01/12/2017

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

31/01/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/09/2017: Internal review. 06/06/2017: Internal review. 09/05/2017: Verified study information with principal investigator.