Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL (NCT02516488) | Clinical Trial Compass
CompletedNot Applicable
Comparison of CLE in Vivo Diagnosis and ex Vivo Examination Against Surgical Histopathology of CPL
United States145 participantsStarted 2015-05
Plain-language summary
Comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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)
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
* Lesion not accessible by EUS guided FNA
* Allergy to fluorescein.
What they're measuring
1
Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)