Clinical Trial 22139

• Overview

  Study Title:

  Confocal Laser Endomicroscopy as an IMaging Biomarker (CLIMB study) for the Diagnosis of Pancreatic Cystic Lesions

  Objective:

  To assess and standardize techniques for acquisition of high-quality imaging with EUS-nCLE, which will enable for in vivo identification and characterization of PCLs. To validate EUS-nCLE as an imaging modality for preoperative classification of mucinous PCLs distinguishing between mucinous and non-mucinous PCLs. To determine the accuracy of detecting advancing neoplasia by distinguishing mucinous PCLs that have advanced neoplasia (high-grade dysplasia or cancer) from those with low-grade dysplasia To distinguish individual distinct types of PCLs To investigate the feasibility of a computer-aided diagnosis (CAD) system to differentiate pancreatic cysts and predict high-grade dysplasia or adenocarcinoma (HGD-Ca) in IPMNs.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Patient age 18 years and older.
  • All patients referred for EUS-FNA of accessible PCL where surgery is contemplated.
  • The minimum size of the cyst should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies.
  • Additional criteria may apply.

• Exclusion Criteria

  Key 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.
  • Additional criteria may apply.

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