Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 28, 2023; 29(12): 1899-1910
Published online Mar 28, 2023. doi: 10.3748/wjg.v29.i12.1899
Linked color imaging vs Lugol chromoendoscopy for esophageal squamous cell cancer and precancerous lesion screening: A noninferiority study
Zi-Xin Wang, Long-Song Li, Song Su, Jin-Ping Li, Bo Zhang, Nan-Jun Wang, Sheng-Zhen Liu, Sha-Sha Wang, Shuai Zhang, Ya-Wei Bi, Fei Gao, Qun Shao, Ning Xu, Bo-Zong Shao, Yi Yao, Fang Liu, En-Qiang Linghu, Ning-Li Chai
Zi-Xin Wang, Long-Song Li, Song Su, Jin-Ping Li, Bo Zhang, Nan-Jun Wang, Sheng-Zhen Liu, Sha-Sha Wang, Shuai Zhang, Ya-Wei Bi, Fei Gao, Qun Shao, Ning Xu, Bo-Zong Shao, Yi Yao, Fang Liu, En-Qiang Linghu, Ning-Li Chai, Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China
Author contributions: Wang ZX and Li LS contributed equally to this work; Chai NL and Linghu EQ contributed to study conception and design; Wang ZX and Li LS contributed to manuscript drafting; Li LS, Su S, Li JP, Wang NJ, Zhang B, Liu SZ, Zhang S, Wang SS, Bi YW, Gao F, Shao Q, Xu N, Shao BZ, Yao Y, and Liu F contributed to data acquisition; Chai NL, Linghu EQ, Li LS and Su S contributed to critical revision of the article for important intellectual content; and all authors issued final approval for the version to be submitted.
Supported by the National Natural Science Foundation of China, No. 81270564 and 82100697.
Institutional review board statement: The study was reviewed and approved by the ethics committee of the Chinese PLA general hospital (Approval No. of Ethics Committee: S2021-145-01).
Clinical trial registration statement: This study was registered in the Chinese clinical trial database (chictr.org) with the number ChiCTR2100045636.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ning-Li Chai, MD, Chief Physician, Professor, Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing 100853, China. csxlily@163.com
Received: November 30, 2022
Peer-review started: November 30, 2022
First decision: December 20, 2022
Revised: December 29, 2022
Accepted: March 9, 2023
Article in press: March 9, 2023
Published online: March 28, 2023
Processing time: 116 Days and 3.4 Hours
ARTICLE HIGHLIGHTS
Research background

Lugol chromoendoscopy (LCE) has served as a standard screening technique in high-risk patients with esophageal cancer. Nevertheless, LCE is not suitable for the general population screening given its side effects. Linked color imaging (LCI) is a novel image-enhanced endoscopic technique that can distinguish subtle differences in mucosal color. It would be beneficial for the general population if LCE can provide similar diagnostic performance to LCI.

Research motivation

We compared the diagnostic performance of LCI with LCE in detecting esophageal squamous cell carcinoma (ESCC) and precancerous lesions. If LCI can replace LCE in detecting esophageal neoplastic lesions, it would be useful for esophageal screening in the general population.

Research objectives

As a novel image-enhanced endoscopic technique, LCI has been confirmed to be superior to white light imaging (WLI) in detecting neoplastic lesions in the upper gastrointestinal tract. We aimed to confirm that the diagnostic performance of LCI is comparable to LCE for the surveillance of ESCC.

Research methods

This was a single-center, prospective, registered clinical study. In this noninferiority study, we prospectively enrolled 543 patients who underwent WLI, LCI and LCE successively. We compared the sensitivity and specificity of LCI and LCE in the detection of esophageal neoplastic lesions. We further used L*a*b* color space to evaluate the color differences of LCI.

Research results

In total, 43 patients were analyzed. The sensitivity of LCI was similar to that of LCE, whereas the specificity of LCI was greater than that of LCE. The LCI procedure time in the esophageal examination was significantly shorter than that of LCE. However, the color difference in LCI was similar in different pathological types.

Research conclusions

Our study showed that LCI is efficient and specific for the surveillance of ESCC without causing discomfort. In the future, LCI, as a promising screening strategy, could replace LCE in the screening of esophageal neoplastic lesions in the general population.

Research perspectives

Because of the low detection rate of esophageal cancer, we were only able to enroll a limited number of neoplastic lesions. In the future, we need to conduct a multicenter study and collect more neoplastic lesions to further evaluate the usefulness of LCI. Further evaluation of the validity of LCI in diagnosing the depth of invasion of ESCC is also warranted.