Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL

Completed

Conditions studied: Cystic Pancreatic Disorders

In brief

Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

Key facts

Study ID

NCT02516488

Run by

Somashekar Krishna

People needed

145

Starts

2015-05-01

Expected to finish

2019-03-01

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For in vivo nCLE (needle-based confocal laser endomicroscopy) (Part 1):
• Patient age 18 years and older
• All patients referred for EUS-FNA (endoscopic ultrasound - fine needle aspiration) of accessible CPL (cystic pancreatic lesion)
• The minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies.
• For ex vivo pCLE (probe-based confocal laser endomicroscopy) (Part 2):
• All patients must satisfy inclusive criteria for in vivo nCLE.
• All patients should have completed EUS-guided nCLE.
• All patients should have a CPL lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology).
• Patient participated and completed in vivo nCLE (Part 1)

You may not qualify if…

• 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
• Lesion not accessible by EUS guided FNA
• Allergy to fluorescein.

Where it is running

• OSU Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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