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Confocal Laser Endomicroscopy for Pancreatic Cysts

This observational study is looking at how well Confocal Laser Endomicroscopy (nCLE) can help doctors diagnose pancreatic cysts. Pancreatic cysts are fluid-filled sacs on the pancreas. Researchers want to see if nCLE, along with other tests like EUS-FNA (Endoscopic Ultrasound with Fine Needle Aspiration) and cyst fluid analysis, can accurately identify different types of cysts and their risk. The study aims to enroll 500 participants aged 18 or older who are considering surgery for their pancreatic cyst, and whose cyst is at least 2.0 cm. The goal is to see how accurate these diagnostic methods are after 48 months, using surgical results as the "gold standard."

Study design
This is an observational study aiming to enroll 500 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo an EUS-guided nCLE imaging procedure, followed by EUS-guided FNA and aspiration of cyst fluid. Your cyst fluid would be analyzed, and surgery may be performed if indicated by your care team.
Compensation
Not stated in the trial record.
Follow-up
The accuracy of the diagnosis and risk-stratification will be measured at 48 months.

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NCT03492151

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Recruiting
Not specifiedAges 18+Observational
Ohio State University Comprehensive Cancer Center
~500 participants
Updated 2025-08-22 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of PCL diagnosis
Measured over 48 months
+1 more outcome measured

Conditions

Pancreatic Cyst

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Intraductal papillary mucinous neoplasmPancreatic CarcinomaPancreatic Cyst

Where it's being run

10 sites across 9 states
New York2
Arizona1
California1
Connecticut1
Indiana1
Maryland1
Massachusetts1
Ohio1

Study leadership

  • Somashekar Krishna, MD, MPH · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Megan Fry
[email protected]
614-293-1056
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient age 18 years or older
All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies

Exclusion

Unable to obtain informed consent
Unable to tolerate the procedure
Women with known pregnancy at time of procedure
Patient age less than 18 years
Bleeding diathesis
Known allergy to fluorescein
Prior pancreatic cancer
Prior pancreatic surgery

What this trial measures

  • Accuracy of PCL diagnosis48 months

    Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.

  • Accuracy of risk-stratification of IPMNs48 months

    Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs