Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-11-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreas Cancer Pancreas Neoplasm, Benign Chronic Pancreatitis Pancreas Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

EUS-FNA needle (Beacon)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EUS-FNB needle (Beacon SharkCore)

Eligibility Criteria

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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