Diagnostic Efficacy of FFOCT Imaging for Tissue Sample Obtained by EUSFNB

Study Overview
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Brief Summary
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In most Asian medical centers, rapid on-site cytology evaluation is not available, the number of needle passes of EUS-FNA is decided by endoscopists. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in sample rapid evaluation.

Detailed Description
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Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. The investigators aimed to evaluate the diagnostic efficacy of FFOCT for the tissue samples obtained from EUS-FNB of pancreas.

Official Title
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Comparing of FFOCT Imaging for Pancreatic Tissue Sample Obtained by EUSFNB and Conventional Histological Examination

Conditions
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Pancreatic Diseases

Intervention / Treatment
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* Device: full-field optical coherence tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tissue samples can be obtained via EUS-FNB Signed informed consent letter Exclusion Criteria: Unable or refuse to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: full-field optical coherence tomography|Pancreatic tissue sample obtained by EUS-FNB will be used for FFOCT imaging. The Images will be sent to trained pathologists for diagnosis. The same tissue sample will be sent to the pathology department for routine histological examination. Compare the diagnoses made by the 2 different methods.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Light-CT | The true positive rate measures the proportion of positives that are correctly identified by Light-CT | 1week after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Light-CT | The true negative rate measures the proportion of positives that are correctly identified by Light-CT | 1week after procedure | 
| The diagnostic efficacy of Light-CT for different pancreatic diseases | Comparing the sensitivity and specificity of FFOCT in the diagnosis of different pancreatic diseases | 1week after procedure | 
| coherence of FFOCT diagnoses by assistant and pathologist | comparing the diagnostic coherence of FFOCT by trained assistant( endoscopist) and trained pathologist | 1week after procedure |