Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer

Study Overview
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Brief Summary
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The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.

Conditions
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Undifferentiated Gastric Cancer

Intervention / Treatment
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* Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France
* Device: white light endoscopy (WLE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery Exclusion Criteria: A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pCLE group<br>The intervention group | Device: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France<br>* The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.<br>|
| Active Comparator: WLE group<br>The control group | Device: white light endoscopy (WLE)<br>* The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of cancer cells in biopsy samples | The percentage of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The expression ratio of tumor marker in biopsy samples | The expression ratio of tumor marker in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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confocal laser endomicroscopy, undifferentiated gastric cancer, target biopsy