NCT01447238

Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Detailed description

Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Conditions

• Pancreatic Cysts

Interventions

Type	Name	Description
DEVICE	Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe	Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure. The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.

Timeline

• Start date: 2010-09-15
• Primary completion: 2018-09-21
• Completion: 2018-09-21
• First posted: 2011-10-06
• Last updated: 2021-04-09

Locations

1 site across 1 country: United States