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临床试验/NCT02921100
NCT02921100Unknown不适用

A Prospective Comparison of Digital Image Analysis and Routine Cytology for the Identification of Pancreatic Neoplasia in Patient Undergoing EUS-FNA

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •who had known or suspected pancreatic malignancy and
  • •in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.

排除标准

  • •not willing to sign informed consent,
  • •cells obtained from FNA for DNA ploidy test less than 200, and/or
  • •patients do not cooperate with follow-up.

研究组 & 干预措施

DNA ploidy test

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test.

干预措施: EUS-FNA (Procedure)

DNA ploidy test

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test.

干预措施: EUS-guided fine needle (Device)

Conventional cytology

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology.

干预措施: cytology (Procedure)

Conventional cytology

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology.

干预措施: EUS-FNA (Procedure)

Conventional cytology

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology.

干预措施: EUS-guided fine needle (Device)

DNA ploidy test

Other

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test.

干预措施: DNA ploidy (Procedure)

结局指标

主要结局

Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test

时间窗: 12 months

次要结局

  • sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy(12 months)
  • specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy(12 months)
  • positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy(12 months)
  • negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Director of gastroenterology department

Changhai Hospital

研究点 (1)

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