Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study) (SharkBITE)
Primary Purpose
Pancreas Cancer, Pancreas Neoplasm, Benign, Chronic Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EUS-FNA needle (Beacon)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreas Cancer
Eligibility Criteria
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.
Sites / Locations
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS tissue sampling
Arm Description
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
Outcomes
Primary Outcome Measures
The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.
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.
Secondary Outcome Measures
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.
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
Duration of pathologist reporting time
During pathologist diagnostic routine reporting period per sample standard is usually 1-2 weeks
Cost benefit analysis of the needle types
An analysis to assess which needle is the most cost-effective
Duration of sampling procedures
Duration of sampling procedures during EUS procedure per patient
Full Information
NCT ID
NCT03532347
First Posted
November 1, 2017
Last Updated
June 7, 2019
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03532347
Brief Title
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
Acronym
SharkBITE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
November 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
Medtronic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreas Neoplasm, Benign, Chronic Pancreatitis, Pancreas Adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive both interventions the order i.e. FNB first or FNA first will be randomised. The pathologists reporting the samples will be blinded to the results with the alternative device
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS tissue sampling
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
EUS-FNA needle (Beacon)
Other Intervention Name(s)
EUS-FNB needle (Beacon SharkCore)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.
Description
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.
Time Frame
During EUS procedure
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
During EUS Procedure
Title
Duration of pathologist reporting time
Description
During pathologist diagnostic routine reporting period per sample standard is usually 1-2 weeks
Time Frame
Per sample anticipated to be 1-2 weeks
Title
Cost benefit analysis of the needle types
Description
An analysis to assess which needle is the most cost-effective
Time Frame
Over study period which is anticipated to be around 1 year
Title
Duration of sampling procedures
Description
Duration of sampling procedures during EUS procedure per patient
Time Frame
During the EUS procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kofi Oppong, Dr
Organizational Affiliation
Consultant Gastroenterologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)
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