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

Somashekar Krishna145 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

145

Conditions

Cystic Pancreatic Disorders

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

OSU Wexner Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Diagnosis of cystic pancreatic lesion (CPL) using nCLE (confocal laser endomicroscopy)

Comparing the ability of nCLE to accurately diagnose the type of CPL by comparing in vivo and ex vivo CLE patterns to final histopathology of surgically resected CPLs.

Time frame: 12 months

Secondary Outcomes

Detection of high-grade dysplasia and/or adenocarcinoma by CLE imaging

Time frame: 12 months

CLE imaging interpretation variation

Calculate inter-observer variation in CLE image interpretation

Time frame: 12 months

Data from ClinicalTrials.gov

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