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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01447238

Enrollment

104

Registered

2011-10-06

Start date

2010-09-15

Completion date

2018-09-21

Last updated

2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cysts

Keywords

pancreatic cysts, EUS/FNA, Needle-based Confocal Laser Endomicroscopy (nCLE), fiber optic imaging, EUS/FNA of pancreatic cysts

Brief 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.

Interventions

DEVICEDirect 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients scheduled for an EUS-FNA procedure of a pancreatic cyst, * Aged above 18 years * Granted written informed consent for the study can be included in the study.

Exclusion criteria

* Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc) * Pregnant or breastfeeding * Allergy to fluorescein * Renal insufficiency

Design outcomes

Primary

Measure	Time frame	Description
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)	From the date of imaging until follow up for 6 months to two years.	Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026