- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532347
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study) (SharkBITE)
June 7, 2019 updated by: Newcastle-upon-Tyne Hospitals NHS Trust
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
This study compares the diagnostic performance of Endoscopic ultrasound (EUS) guided fine needle aspiration and EUS guided core biopsy (SharkCore) in patients with a solid pancreatic mass.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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 at 7 days.
Participants will be asked if they have developed any new symptoms since the procedure and whether they have had to seek medical attention for this.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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Newcastle Upon Tyne
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Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients 18 years and above with a solid pancreatic mass of any size, needing to Undergo the EUS examination to collect sample for diagnosis will be recruited for the study. The definition of a solid pancreatic mass will be based on an ultrasound or a CT scan result or based on the findings of a EUS examination done prior.
- Patients should have the ability and be willing to give informed consent
Exclusion Criteria:
- Cysts that do not have a significant solid component will be excluded
- Any contraindication to pancreatic biopsy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EUS tissue sampling
Device: EUS-FNA needle (Beacon) 3 passes 25g needle from head of pancreas; 22g needle from neck, body and tail Device:EUS-FNB needle (Beacon Sharkcore) 3 passes 25g needle from head of pancreas; 22g needle from neck, body and tail |
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 trans gastric puncture.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.
Time Frame: During EUS procedure
|
The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions during the EUS procedure.
|
During EUS procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the adequacy of the sample obtained with standard Beacon FNA needle compared with the SharkCore core biopsy needle in the sampling of solid pancreatic mass lesions.
Time Frame: During EUS Procedure
|
To compare the adequacy of the sample obtained with standard Beacon FNA needle compared with the SharkCore core biopsy needle in the sampling of solid pancreatic mass lesions during EUS procedure per patient
|
During EUS Procedure
|
Duration of pathologist reporting time
Time Frame: Per sample anticipated to be 1-2 weeks
|
During pathologist diagnostic routine reporting period per sample standard is usually 1-2 weeks
|
Per sample anticipated to be 1-2 weeks
|
Cost benefit analysis of the needle types
Time Frame: Over study period which is anticipated to be around 1 year
|
An analysis to assess which needle is the most cost-effective
|
Over study period which is anticipated to be around 1 year
|
Duration of sampling procedures
Time Frame: During the EUS procedure
|
Duration of sampling procedures during EUS procedure per patient
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During the EUS procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kofi Oppong, Dr, Consultant gastroenterologist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2017
Primary Completion (Actual)
May 4, 2018
Study Completion (Actual)
November 4, 2018
Study Registration Dates
First Submitted
November 1, 2017
First Submitted That Met QC Criteria
May 9, 2018
First Posted (Actual)
May 22, 2018
Study Record Updates
Last Update Posted (Actual)
June 10, 2019
Last Update Submitted That Met QC Criteria
June 7, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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