Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03532347
• Collaborator: Medtronic (Industry)
• Enrollment: 108
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.4
• Patients Per Site Per Month: 6.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer; Pancreas Neoplasm, Benign; Chronic Pancreatitis; Pancreas Adenocarcinoma	Device: EUS-FNA needle (Beacon)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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 deviceAll 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)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: May 22, 2017
• Actual Primary Completion Date: May 4, 2018
• Actual Study Completion Date: Nov 4, 2018

Arms and Interventions

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	Device: EUS-FNA needle (Beacon); 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: EUS-FNB needle (Beacon SharkCore)

Outcome Measures

Primary Outcome Measures

1. The sensitivity of standard Beacon FNA needle compared with the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions. [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.

Secondary Outcome Measures

1. 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]

   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

2. Duration of pathologist reporting time [Per sample anticipated to be 1-2 weeks]

   During pathologist diagnostic routine reporting period per sample standard is usually 1-2 weeks

3. Cost benefit analysis of the needle types [Over study period which is anticipated to be around 1 year]

   An analysis to assess which needle is the most cost-effective

4. Duration of sampling procedures [During the EUS procedure]

   Duration of sampling procedures during EUS procedure per patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle	Newcastle Upon Tyne	United Kingdom	NE7 7DN

Sponsors and Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust
• Medtronic

Investigators

• Principal Investigator: Kofi Oppong, Dr, Consultant Gastroenterologist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT03532347
• Other Study ID Numbers: 8090
• First Posted: May 22, 2018
• Last Update Posted: Jun 10, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Pancreatic Neoplasms; Neoplasms; Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Jun 10, 2019