RecruitingNCT03492151

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

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

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

500 participants

Start Date

Oct 1, 2018

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cyst

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special microscopic imaging technique called confocal laser endomicroscopy (CLE) — which allows doctors to look at the cells lining a cyst in real time during an endoscopy — to see if it can better classify pancreatic cysts and reduce the need for unnecessary surgery. **You may be eligible if...** - You are 18 or older - You have a pancreatic cyst that is at least 2 cm in size (found on prior CT or MRI scan) - You have been referred for a standard endoscopic ultrasound procedure with fine needle aspiration (EUS-FNA) and surgery is being considered **You may NOT be eligible if...** - You cannot provide informed consent - You are unable to tolerate the procedure - You are pregnant - You have a bleeding disorder - You have a known allergy to fluorescein dye (used during the procedure) - You have a history of pancreatic cancer - You have had previous pancreatic surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(10)

Mayo Clinic Scottsdale Campus

Scottsdale, Arizona, United States

Stanford Hospital

Stanford, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

NYU Langone Health

Garden City, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

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NCT03492151

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