Biopsy, Fine-Needle Clinical Trial
Official title:
A Prospective Comparison of Digital Image Analysis and Routine Cytology for the Identification of Pancreatic Neoplasia in Patient Undergoing EUS-FNA
150 patients who had suspected pancreatic malignancy were planed to be enrolled in this study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital image analysis and conventional cytology respectively. The investigators aim to compare the efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the investigators also collected the blood sample of each enrolled patient for advanced study.
The conventional cytology was interpreted independently by two cytopathologists, both of
whom are blinded to the DIA results. The conventional cytologic diagnosis were classified as
no abnormal cells, atypical cells, suspicious malignant cells and malignant cells. The
specimens were examined by two experienced cytopathologists. Any disagreement on specimens
would refer to a third cytopathologist to provide a final consensus. The former two
diagnosis were determined to be positive, and the latter two to be negative.
DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro
photometric principles and a sister technique to flow cytometry. Computer analysis of the
pixels produces a digital image of the nucleus and other cellular constituents.
Quantification of DNA content, chromatin distribution, and nuclear morphology can be
determined and suggest features of malignancy. ThinPrep specimens were prepared as
previously described.Per specimen, the DNA content of at least 500 cells was selected for
quantification using an image analyzer (Landing Medical High-tech, Wuhan, Hubei, China) and
the mean integrated optical density lymphocytes served as an internal standard control. All
other histograms suggesting the presence of (1) any cells with DNA>5c; (2) diploidy cells
with a very high proliferation rate where 10% or more of the total cells were found in the
proliferation fraction; and (3) a population of aneuploidy stem cells, were called positive
for malignancy. Images of cells reporting a DNA amount greater than 5c were examined
microscopically by a cytotechnologist to exclude any artifacts such as dust, air bubbles,
overlapping cells, etc. from the >5c cell galleries.
All the final diagnosis are to be confirmed by histopathology or a long term follow up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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