Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology
Conditions
Interventions
Adult patients with a solid pancreatic mass of any size, requiring EUS guided tissue sampling to make a diagnosis will be eligible to participate. Participants will be randomised to an initial 3 passe
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Planned Sample Size: 108; UK Sample Size: 108
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Adequacy of the samples obtained as reported by the pathologist utilising a standard methodology 2. The duration of pathologist reporting time 3. Overall costs including device, pathology processing and pathology lab time | — |
Countries
United Kingdom
Contacts
Public ContactHannah Stevenson
Outcome results
None listed