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

Early Gastric Cancer Clinical Trial

Official title:

Application of Linked Color Imaging（LCI） in Diagnosis of Early Gastric Cancer(EGC): a Multicenter,Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03661671
• Other study ID #: LCI2018
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2018
• Source: Changhai Hospital
• Contact: Dong Wang, M.D
• Phone: 8613816758802
• Email: dongwang0901[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• LCI+white light
Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia

Locations

Country	Name	City	State
China	Department of Gastroenterology, Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (14)

Lead Sponsor

Collaborator

Changhai Hospital

307 Hospital of PLA, Chongqing University Cancer Hospital, First People's Hospital of Hangzhou, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guilin Medical University, China, Jiangsu Province Hospital of Traditional Chinese Medicine, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Wuhan University, Xi'an Central Hospital, Xiangya Hospital of Central South University, Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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 2 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure
Secondary	Specificity of detecting gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure
Secondary	Sensitivity of detecting gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure