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

Naval Military Medical University

Status: Unknown

Conditions: Early Gastric Cancer

Treatments: Diagnostic Test: LCI+white light

Study type: Interventional

Funder types: Other

Identifiers

NCT03661671

LCI2018

Details and patient eligibility

About

the purpose of this study is to evaluate application value of LCI in the diagnosis of early gastric cancer.

Full 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,400 participants in 2 patient groups

LCI+white light

Experimental group

Description:

Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Treatment:

Diagnostic Test: LCI+white light

White light

No Intervention group

Description:

Using white light only.