Using confocal laser endomicroscopy to diagnose pancreatic cysts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of confocal laser endomicroscopy (nCLE) as an imaging biomarker for diagnosing pancreatic cystic lesions (PCL). Patients referred for endoscopic ultrasound (EUS) evaluation of PCL will undergo nCLE imaging, followed by EUS-guided fine needle aspiration (FNA) for cyst fluid analysis. The results from the cyst fluid, including cytology and molecular analysis, will be compared against surgical histopathology to determine the accuracy of the imaging technique. The study seeks to improve diagnostic accuracy and guide treatment decisions for patients with pancreatic cysts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Mayo Clinic Scottsdale Campus
  Scottsdale, Arizona, United States Recruiting
• Stanford Hospital
  Stanford, California, United States Recruiting
• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• The Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• NYU Langone Health
  Garden City, New York, United States Recruiting

Study contacts

• Principal investigator: Somashekar Krishna, MD, MPH — Ohio State University
• Study coordinator: Megan Fry
• Email: Megan.Fry@osumc.edu
• Phone: 614-293-1056

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.