Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

NCT03532347 | Completed

• 1 other identifier: 8090
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Pancreas Neoplasm, Benign; Chronic Pancreatitis; Pancreas Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  During EUS procedure

Secondary Outcomes (4)

• 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

• Duration of pathologist reporting time

  Per sample anticipated to be 1-2 weeks

• Cost benefit analysis of the needle types

  Over study period which is anticipated to be around 1 year

• Duration of sampling procedures

  During the EUS procedure

Study Arms (1)

EUS tissue sampling

EXPERIMENTAL

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)

Interventions

EUS-FNA needle (Beacon) DEVICE

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.

Also known as: EUS-FNB needle (Beacon SharkCore)

EUS tissue sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cysts that do not have a significant solid component will be excluded
• Any contraindication to pancreatic biopsy.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Medtronic: collaborator

Study Sites (1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kofi Oppong, Dr

  Consultant Gastroenterologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: May 22, 2018
• Study Start: May 22, 2017
• Primary Completion: May 4, 2018
• Study Completion: November 4, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

GB (1)