Pancreatic Cancer
Conditions
Brief summary
This investigation aims to demonstrate the feasibility of the lbFNA device for the first time in pancreatic cysts in humans. This study will be used as a base for further investigations on the safety and diagnostic accuracy of the lbFNA device.
Interventions
DEVICELoop Brush Fine Needle Aspiration
Loop Brush Fine Needle Aspiration (lbFNA) device is an endoscopy instrument used in this investigation for the puncture, brushing and aspiration of pancreatic cystic lesions prior to surgical removal of the pancreatic cystic lesion.
Sponsors
Urban Arnelo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pancreatic cystic lesions that require surgical resection according to MDT conference * Assessed as fit for surgery * Age \>18 years * Given written informed consent to participate
Exclusion criteria
* Pregnancy * Cyst not accessible by lbFNA * Cyst not accessible for resection that includes the puncture canal for lbFNA * Cyst with calcified content * Inability to understand written or oral information, which hinders the ability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrity of the lbFNA device | From start of the lbFNA procedure until completion of the lbFNA procedure. | Integrity of the device after withdrawing from the patient, evaluated according to a separate inspection protocol with special focus on the loop. |
Countries
Sweden
Contacts
CONTACTUrban Arnelo
Outcome results
None listed