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Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study)

NCT03532347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-06-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Newcastle-upon-Tyne Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Kofi Oppong, Dr · Consultant Gastroenterologist

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2018-05-04
Completion
2018-11-04

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532347 on ClinicalTrials.gov