Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Conventional cytology
Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology.
cytology
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.
EUS-FNA
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
EUS-guided fine needle
DNA ploidy test
Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test.
DNA ploidy
DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry.Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy
EUS-FNA
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
EUS-guided fine needle
Interventions
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cytology
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.
DNA ploidy
DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry.Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy
EUS-FNA
All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
EUS-guided fine needle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.
Exclusion Criteria
2. cells obtained from FNA for DNA ploidy test less than 200, and/or
3. patients do not cooperate with follow-up.
18 Years
90 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Director of gastroenterology department
Principal Investigators
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Dong Wang, Dr.
Role: STUDY_DIRECTOR
Digestive endoscopic center of Changhai Hospital
Locations
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Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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DNA ploidy and CC
Identifier Type: -
Identifier Source: org_study_id