Linked Color Imaging Can Improve Detection Rate of Early Gastric Cancer in a High-Risk Population: A Multi-Center Randomized Controlled Clinical Trial

Jie Gao 1, Xiaofeng Zhang 4, Qianqian Meng 1, Hangbin Jin 4, Zhenhua Zhu 7, Zhijie Wang 1, Wei Qian 1, Luoman Zhang 1, Yan Liu2, Min Min 2, Xing Chen3, Haihua Chen3, Shutang Han5, Jun Xiao5, Yalei Wang6, Wei Han6, Yapi Lu8, Shuntian Cai8, Weiqing Chen9, Wen Ji9, Xuhua Xiao10, Qinghua Zheng10, Beiping Zhang11, Wenbin Wu11, Guanghui Lian12, Xiaowei Liu12, Qiu Zhao13, Min Chen13, Kun Zhuang14, Wangli Si14, Xingang Shi1, Youxiang Chen7, Zhaoshen Li1, Dong Wang1,15

Dig Dis Sci. 2020 May 4

Background: Early diagnosis of gastric cancer is difficult in China due to the lack of a valid method for endoscopic screening. Early gastric cancer, especially flat gastric cancer, lacks specific endoscopic features. Many cases appear to be similar to ordinary gastritis cases under normal white light endoscopy, which can lead to misdiagnosis.

Aims: In order to find a new method to improve detection rate of early gastric cancer in China, we designed a trial to validate linked color imaging (LCI) for screening of early gastric cancer in a high-risk population, as compared to white light imaging (WLI).

Method: Subjects were randomly allocated to either the LCI + WLI or WLI group and then subjected to gastroscopy and all endoscopies were made after special preparation. All endoscopists had knowledge of this experiment. The main indicator was the rate of detection of gastric neoplastic lesions. The difference in the detection rate between the two groups is reported.

Results: The detection rate was 4.31% in the WLI group and 8.01% in the LCI + WLI group. This is a difference of 3.70% with a P value < 0.001 and an OR (95% CI) of 1.934 (1.362, 2.746). The lower limit of the 95% CI was greater than 0, and the superiority margin was 1%.

Conclusion: The detection rate of gastric neoplastic lesions was higher in the LCI + WLI group than in the WLI group, LCI might be an effective method for screening early gastric cancer.

1 Department of Gastroenterology, Changhai Hospital, The Second Military University, Shanghai, China
2 Department of Gastroenterology, The Fifth Medical Centre, Chinese PLA General Hospital (Former 307th Hospital of the PLA), Beijing, China
3 Endoscopy Center, Shanxi Cancer Hospital, Taiyuan, China
4 Department of Gastroenterology, Afliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine, Hangzhou, China
5 Jiangsu Province Hospital of TCM and Afliated Hospital of Nanjing University of TCM, Nanjing, China
6 The First Afliated Hospital of Anhui Medical University, Hefei, China
7 The First Afliated Hospital of Nanchang University, Nanchang, China
8 Department of Gastroenterology, Zhongshan Hospital Afliated to Xiamen University, Xiamen, China
9 Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital and Chongqing
Cancer Institute and Chongqing Cancer Hospital, Chongqing, China
10 Afliated Hospital of Guilin Medical University, Guilin, China
11 Guangdong Provincial TCM Hospital, Guangzhou, China
12 Gastroenterology Department of Xiangya Hospital, CSU, Changsha, China
13 Zhongnan Hospital of Wuhan University, Wuhan, China
14 Xi’an Central Hospital, Xi’an, China
15 Digestive Endoscopy Center, Changhai Hospital, The Second Military University, Shanghai, China