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

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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Key information

Conditions

Pancreatic Cysts Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

Device

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.

Other names: Cellvizio, nCLE, Spyglass

Primary outcomes

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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2018
Study completion: 2018
First posted: Oct 6, 2011
Registry last updated: Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed