Using confocal laser endomicroscopy to diagnose pancreatic cysts

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

This study is testing a new imaging technique to see if it can help doctors better diagnose pancreatic cysts in patients who are already being checked for these issues.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (other)
• Locations: 10 sites (Scottsdale, Arizona and 9 other locations)
• Trial ID: NCT03492151 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are referred for EUS-FNA of pancreatic cysts that are 2.0 cm or larger and for whom surgery is being considered.

Not a fit: Patients who are unable to provide informed consent, have prior pancreatic cancer, or have conditions that prevent them from tolerating the procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses of pancreatic cysts, potentially improving patient outcomes and treatment strategies.

How similar studies have performed: While the use of confocal laser endomicroscopy in this context is relatively novel, similar imaging techniques have shown promise in other studies for improving diagnostic accuracy in various conditions.

Eligibility criteria

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 this trial is running

Scottsdale, Arizona and 9 other locations

• 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)
• Parkview Hospital Randallia — Fort Wayne, Indiana, United States (ACTIVE_NOT_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)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Somashekar Krishna, MD, MPH — Ohio State University
• Study coordinator: Megan Fry

Conditions: Pancreatic Cyst, Confocal laser endomicroscopy, pancreatic cancer, IPMN