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

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

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

Study Overview

• Status: Unknown
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Diagnostic test: LCI+white light

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 Type: Interventional
• Enrollment (Anticipated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Gao, M.D; Phone Number: 8613761272863; Email: jesseegao@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCI+white light; Using white light firstly to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia	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
No Intervention: White light; Using white light only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of detecting gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure
Sensitivity of detecting gastric neoplastic lesion	Include early gastric caner,high grade dysplasia low grade dysplasia and adenoma	immediately following the procedure

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Guilin Medical University, China; 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; Guangdong Provincial Hospital of Traditional Chinese Medicine; Xiangya Hospital of Central South University; Wuhan University; Xi'an Central Hospital
• Investigators: Principal Investigator: Zhaoshen Li, M.D, Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Linked-color imaging; Detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: LCI2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No