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

Somashekar Krishna

Status: Completed

Conditions: Cystic Pancreatic Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT02516488

2014C0205

Details and patient eligibility

About

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

Full description

The primary objective of the study is to assess the ability of nCLE (AQ-Flex) to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs. The primary endpoints are whether or not the CLE diagnosis correlates with final diagnosis (yes vs. no).

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.