Endoscopic ultrasound guided pancreatic tissue sampling (SharkBITE Study)

Not Applicable

Completed

• Conditions: Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs; Cancer; Pancreatic cancer

• Registration Number: ISRCTN10173433
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-02
• Study Completion: 2018-11-30
• Last Update Posted: 29 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Planned Sample Size: 108; UK Sample Size: 108

Exclusion Criteria

1. A greater than 50% cystic component to the pancreatic mass
2. Any contraindication to pancreatic biopsy
3. Patients with a metal biliary stent in situ and target lesion in the head of pancreas
4. Less than 18 years of age
5. Unable and unwilling to give consent
6. Unwilling to undergo additional biopsies
7. Unable to understand English
8. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of the 2 needle types will be measured by comparing the sensitivity of standard Beacon FNA needle to the SharkCore (FNB) core biopsy needle in the sampling of solid pancreatic mass lesions.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Adequacy of the samples obtained as reported by the pathologist utilising a standard methodology<br> 2. The duration of pathologist reporting time<br> 3. Overall costs including device, pathology processing and pathology lab time<br>