Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).

Detailed Description
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Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.

Official Title
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Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers

Conditions
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Stomach Neoplasms, Precancerous Conditions

Intervention / Treatment
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* Device: Endomicroscope (Pentax, Tokyo, Japan)
* Device: Gastroscopes (Pentax, Tokyo, Japan)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45 years old ≤ age < 80 years old Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy Exclusion Criteria: Known cancers or gastrectomy Scheduled for endoscopic treatment Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss Under conditions such as: ascites jaundice liver cirrhosis impaired renal function coagulopathy fever pregnancy breastfeeding Inability to provide informed consent Known allergy to fluorescein sodium

Ages Eligible for Study
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Minimum Age: 45 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: 1 confocal laser endomicroscopy<br>Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy. | Device: Endomicroscope (Pentax, Tokyo, Japan)<br>* A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.<br>* Other names: Pentax EC3870K endomicroscope;|
| Active Comparator: 2 Conventional endoscopy<br>Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy. | Device: Gastroscopes (Pentax, Tokyo, Japan)<br>* Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)<br>* Other names: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach, endoscopy, neoplasms