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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-15

Study Completion Date

2018-09-21

Brief Summary

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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).

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Detailed Description

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

Conditions

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Pancreatic Cysts

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Cellvizio nCLE Spyglass

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No