Actively Recruiting
Using Confocal Laser Endomicroscopy to Diagnose Pancreatic Cystic Lesions in Patients Undergoing EUS-FNA
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-08-22
500
Participants Needed
10
Research Sites
N/A
Total Duration
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
Research Team
M
Megan Fry
D
Diana Burke
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