Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion.
Stephen A Firkins, Wei Chen, Somashekar G Krishna
https://pubmed.ncbi.nlm.nih.gov/33039474Actively Recruiting
Age: 18Years +
All Genders
ID03492151
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-08-22
500
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
A
American College of Gastroenterology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pancreatic cystic lesions (PCL) to improve diagnosis using confocal laser endomicroscopy (nCLE) combined with endoscopic ultrasound (EUS) and cyst fluid analysis. This observational study involves patients referred for EUS evaluation of PCL at academic centers, aiming to assess the accuracy of diagnosing PCL and the risk stratification of intraductal papillary mucinous neoplasms (IPMNs) over 48 months. Participants undergo EUS-guided nCLE imaging followed by EUS-guided fine needle aspiration (FNA) to collect cyst fluid. The fluid is tested for carcinoembryonic antigen (CEA), cytology, and molecular markers as part of standard care. Based on these results and multidisciplinary tumor board recommendations, surgery may be performed, with surgical histopathology serving as the definitive diagnosis. During the study, patients provide consent and receive EUS procedures with imaging and fluid sampling. Researchers measure diagnostic accuracy and imaging quality over 48 months. Most participants are expected to have surgical resection after EUS. The study monitors the accuracy of diagnosis and risk assessment, guiding future care for pancreatic cysts.
CONDITIONS
Brief Title
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older
- Patients referred for EUS-FNA of accessible pancreatic cystic lesions where surgery is considered
- Pancreatic cyst size of at least 2.0 cm as shown by prior imaging
You will not qualify if you...
- Unable to provide informed consent
- Unable to tolerate the EUS procedure
- Pregnant women at time of procedure
- Patient age under 18 years
- Bleeding disorders
- Known allergy to fluorescein dye
- History of pancreatic cancer
- Previous pancreatic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single day
Participants undergo confocal laser endomicroscopy imaging to diagnose pancreatic cystic lesions.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 48 months
Participants are monitored for up to 48 months to assess diagnosis accuracy and imaging quality.
Periodic visits during the monitoring period
Trial Site Locations
Total: 10 locations
1
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Stanford Hospital
Stanford, California, United States, 94305
Actively Recruiting
3
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
Active, Not Recruiting
5
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
NYU Langone Health
Garden City, New York, United States, 11530
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
10
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
M
Megan Fry
D
Diana Burke
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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