Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (NCT03492151)
🩺 Plain-English Summary (8th-Grade Level)
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (9 items).
Location: Mayo Clinic Scottsdale Campus — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- Mayo Clinic Scottsdale Campus — Scottsdale, Arizona
- Stanford Hospital — Stanford, California
- Yale School of Medicine — New Haven, Connecticut
- Parkview Hospital Randallia — Fort Wayne, Indiana
- The Johns Hopkins Hospital — Baltimore, Maryland
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- NYU Langone Health — Garden City, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- Baylor College of Medicine — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.