Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)

Not Applicable

• Conditions: Early Gastric Cancer
• Interventions: Diagnostic Test: LCI+white light

• Registration Number: NCT03661671
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-05
• Last Update Submitted: 2018-09-05
• Study First Posted: 2018-09-07
• Last Update Posted: 2018-09-07
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCI+white light	LCI+white light	Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Primary Outcome Measures

Name	Time	Method
Detection rate of gastric neoplastic lesion	immediately following the procedure	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Secondary Outcome Measures

Name	Time	Method
Sensitivity of detecting gastric neoplastic lesion	immediately following the procedure	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma
Specificity of detecting gastric neoplastic lesion	immediately following the procedure	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma

Trial Locations

Locations (1)

Department of Gastroenterology, Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China