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| ID | Type | Description | Link |
|---|---|---|---|
| 2006GG3202022 | |||
| 2007(Ministry of Health) |
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The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 confocal laser endomicroscopy | Experimental | Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy. |
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| 2 Conventional endoscopy | Active Comparator | Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endomicroscope (Pentax, Tokyo, Japan) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. | one year |
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Inclusion Criteria:
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:
Inability to provide informed consent
Known allergy to fluorescein sodium
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| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li, PhD. MD. | Department of Gastroenterology, Qilu Hospital, Shandong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020699 | Gastroscopes |
| ID | Term |
|---|---|
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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| Gastroscopes (Pentax, Tokyo, Japan) | Device | Conventional white light gastroscopes (Pentax EG-2940 gastroscopes) |
|
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| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D013523 |
| Surgical Equipment |