Clinical trial NCT03661671: Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC)
Official title: Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer
Keywords: Linked-color imaging
Detection
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Province Cancer Hospital
name: First People's Hospital of Hangzhou
name: 307 Hospital of PLA
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Anhui Medical University
name: The First Affiliated Hospital of Nanchang University
name: Zhongshan Hospital Xiamen University
name: Chongqing University Cancer Hospital
name: Guilin Medical University, China
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Xiangya Hospital of Central South University
name: Wuhan University
name: Xi'an Central Hospital
First posted: 2018-09-07
Enrollment: 2400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of gastric neoplastic lesion
timeFrame: immediately following the procedure
Secondary outcomes:
measure: Specificity of detecting gastric neoplastic lesion
timeFrame: immediately following the procedure
measure: Sensitivity of detecting gastric neoplastic lesion
timeFrame: immediately following the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Department of Gastroenterology, Changhai Hospital, Second Military Medical University
name: Zhaoshen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.
citation: Okada M, Sakamoto H, Takezawa T, Hayashi Y, Sunada K, Lefor AK, Yamamoto H. Laterally Spreading Tumor of the Rectum Delineated with Linked Color Imaging Technology. Clin Endosc. 2016 Mar;49(2):207-8. doi: 10.5946/ce.2015.077. Epub 2016 Feb 12. No abstract available.
citation: Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.