Feasibility of the Loop Brush EUS-FNA for Characterization of Pancreatic Cysts: Pilot Clinical Investigation

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

• Loop Brush Fine Needle Aspiration · DEVICE

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Department of Surgery, Umeå University Hospital, Umeå, Sweden