Early Gastric Cancer
Conditions
Keywords
Linked-color imaging, Detection
Brief summary
the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.
Detailed description
The detection rate of early gastric cancer is still very low in China. The investigators need a new and effective screening method to improve the detection rate. LCI (linked-color imaging)is a new model of laser endoscopy which can provide brighter image. LCI can provide clear image which can make red part redder and white part whiter, so suspicious lesion could be found easier. The study of this randomized controlled trial is to discuss effectiveness of LCI in the diagnosis of early gastric cancer and to find a new method to improve the detection rate of early gastric cancer in China.
Interventions
DIAGNOSTIC_TESTLCI+white light
Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
Sponsors
Shanxi Province Cancer Hospital
First People's Hospital of Hangzhou
307 Hospital of PLA
Jiangsu Province Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Nanchang University
Zhongshan Hospital Xiamen University
Chongqing University Cancer Hospital
Guilin Medical University, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Xiangya Hospital of Central South University
Wuhan University
Xi'an Central Hospital
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. High-risk group of gastric cancer: H. pylori infection; previously suffering from chronic atrophic gastritis, intestinal metaplasia, gastric ulcer, gastric polyps, residual stomach after surgery, hypertrophic gastritis, malignant anemia and other precancerous diseases of gastric cancer; 2. First degree relatives of patients with gastric cancer; 3. There are other high risk factors for gastric cancer (high salt, salted diet, smoking, heavy drinking, etc.). 4. Patients with early gastric cancer treated with endoscopic therapy (ESD, EMR). 5. The informed consent has been signed.
Exclusion criteria
1. The TNM classification of cancer is consistent with those diagnosed by T2 above. 2. Patients with abnormal blood coagulation function or taking anticoagulants can not biopsy. 3. There were contraindications for gastroscopy. 4. A patient without self judgement; 5. Those who did not sign informed consent. 6. Previous gastroscopy has found suspicious lesions requiring careful examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of gastric neoplastic lesion | immediately following the procedure | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of detecting gastric neoplastic lesion | immediately following the procedure | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma |
| Sensitivity of detecting gastric neoplastic lesion | immediately following the procedure | Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma |
Countries
China
Contacts
Primary ContactDong Wang, M.D
Backup ContactJie Gao, M.D
Outcome results
None listed