Europe PMC

This website requires cookies, and the limited processing of your personal data in order to function. By using the site you are agreeing to this as outlined in our privacy notice and cookie policy.

Optical enhancement mode 2 improves the detection rate of gastric neoplastic lesion in high-risk populations: A multicenter randomized controlled clinical study.

Show less

Author information

Affiliations

  • 1. Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.
      Authors
    • An W 1
    • Su XJ 1
    • Sun HX 1
    • Shi XG 1
    • Hu LH 1
    • Li ZS 1
    (6 authors)
  • 2. Department of Gastroenterology, Peking University Cancer Hospital, Beijing, China.
      Authors
    • Wu Q 2
    • Wang J 2
    (2 authors)
  • 3. Department of Gastroenterology, Tangdu Hospital the Air Force Military Medical University, Xi'an, China.
      Authors
    • Dou WJ 3
    • Liu ZX 3
    (2 authors)
  • 4. Department of Gastroenterology, Hebei General Hospital, Shijiazhuang, China.
      Authors
    • Liu GF 4
    • Zhang YH 4
    (2 authors)
  • 5. Department of Gastroenterology, Tongji Hospital of Tongji University, Shanghai, China.
      Authors
    • Xu SC 5
    • Chen Y 5
    (2 authors)
    • Show all (14)

ORCIDs linked to this article

United European Gastroenterology Journal, 16 May 2024, 12(6):772-779
https://doi.org/10.1002/ueg2.12577 PMID: 38753528 PMCID: PMC11250407

This article is in the Europe PMC Open access subset. Refer to the copyright information in the article for licensing details.
Free full text in Europe PMC

Abstract 

Objectives

Detection of early neoplastic lesions is crucial for improving the survival rates of patients with gastric cancer. Optical enhancement mode 2 is a new image-enhanced endoscopic technique that offers bright images and can improve the visibility of neoplastic lesions. This study aimed to compare the detection of neoplastic lesions with optical enhancement mode 2 and white-light imaging (WLI) in a high-risk population.

Methods

In this prospective multicenter randomized controlled trial, patients were randomly assigned to optical enhancement mode 2 or WLI groups. Detection of suspicious neoplastic lesions during the examinations was recorded, and pathological diagnoses served as the gold standard.

Results

A total of 1211 and 1219 individuals were included in the optical enhancement mode 2 and WLI groups, respectively. The detection rate of neoplastic lesions was significantly higher in the optical enhancement mode 2 group (5.1% vs. 1.9%; risk ratio, 2.656 [95% confidence interval, 1.630-4.330]; p < 0.001). The detection rate of neoplastic lesions with an atrophic gastritis background was significantly higher in the optical enhancement mode 2 group (8.6% vs. 2.6%, p < 0.001). The optical enhancement mode 2 group also had a higher detection rate among endoscopists with different experiences.

Conclusions

Optical enhancement mode 2 was more effective than WLI for detecting neoplastic lesions in the stomach, and can serve as a new method for screening early gastric cancer in clinical practice.

Clinical registry

United States National Library of Medicine (https://www.

Clinicaltrials

gov), ID: NCT040720521.

Free full text 

Logo of uegLink to Publisher's site
United European Gastroenterol J. 2024 Jul; 12(6): 772–779.
Published online 2024 May 16. https://doi.org/10.1002/ueg2.12577
PMCID: PMC11250407
PMID: 38753528

Optical enhancement mode 2 improves the detection rate of gastric neoplastic lesion in high‐risk populations: A multicenter randomized controlled clinical study

Wei An, 1 Qi Wu, 2 Xiao‐Ju Su, 1 Hong‐Xin Sun, 1 Jing Wang, 2 Wei‐Jia Dou, 3 Zhen‐Xiong Liu, 3 Gai‐Fang Liu, 4 Yue‐Han Zhang, 4 Shu‐Chang Xu, 5 Ying Chen, 5 Hao Zhang, 6 Bin Zhang, 6 Ping Li, 7 Si‐Yu Sun, 8 Sheng Wang, 8 Wen Liu, 8 Xiao‐Feng Zhang, 9 Yu‐Shu Zhang, 10 Yi‐Jun Xu, 10 Mei Liu, 11 Xin‐Xia Feng, 11 Xiu‐Li Zuo, 12 Guang‐Chao Li, 12 Li‐Dong Xu, 13 Dong Wang,corresponding author 14 Xin‐Gang Shi,corresponding author 1 Liang‐Hao Hu,corresponding author 1 and Zhao‐Shen Licorresponding author 1
Author information Article notes Copyright and License information Disclaimer

Associated Data

Supplementary Materials
Data Availability Statement

Abstract

Objectives

Detection of early neoplastic lesions is crucial for improving the survival rates of patients with gastric cancer. Optical enhancement mode 2 is a new image‐enhanced endoscopic technique that offers bright images and can improve the visibility of neoplastic lesions. This study aimed to compare the detection of neoplastic lesions with optical enhancement mode 2 and white‐light imaging (WLI) in a high‐risk population.

Methods

In this prospective multicenter randomized controlled trial, patients were randomly assigned to optical enhancement mode 2 or WLI groups. Detection of suspicious neoplastic lesions during the examinations was recorded, and pathological diagnoses served as the gold standard.

Results

A total of 1211 and 1219 individuals were included in the optical enhancement mode 2 and WLI groups, respectively. The detection rate of neoplastic lesions was significantly higher in the optical enhancement mode 2 group (5.1% vs. 1.9%; risk ratio, 2.656 [95% confidence interval, 1.630–4.330]; p < 0.001). The detection rate of neoplastic lesions with an atrophic gastritis background was significantly higher in the optical enhancement mode 2 group (8.6% vs. 2.6%, p < 0.001). The optical enhancement mode 2 group also had a higher detection rate among endoscopists with different experiences.

Conclusions

Optical enhancement mode 2 was more effective than WLI for detecting neoplastic lesions in the stomach, and can serve as a new method for screening early gastric cancer in clinical practice.

Clinical Registry

United States National Library of Medicine (https://www.clinicaltrials.gov), ID: NCT040720521.

Keywords: early gastric cancer, endoscopic screening

Key summary

Summarize the established knowledge on this subject

  • Esophagogastroduodenoscopy with white‐light imaging (WLI) is the most common technique used for screening early gastric cancer (EGC) at present. However, the sensitivity of WLI for detecting EGC is not satisfactory. New image‐enhanced endoscopy (IEE) techniques could be an effective method to increase the detection rate of EGC.

What are the significant and/or new findings of this study?

  • The detection rate of neoplastic lesions was significantly higher in the optical enhancement mode 2 group, especially in the background of atrophic gastritis.

INTRODUCTION

Gastric cancer is one of the most common cancers in the world, ranking fifth in incidence and fourth in mortality globally. 1 The incidence rates of gastric cancer are the highest in Eastern Asia, but the age‐standardized 5‐year net survival rates in South Korea (68.9%) and Japan (60.3%) are higher than those in other countries. 2 Early detection of gastric cancer is a key factor contributing to the favorable survival in these countries.

In the absence of established screening procedures for EGC, esophagogastroduodenoscopy (EGD) with WLI is the most common technique used for screening EGC at present. However, the sensitivity of WLI for detecting EGC is not satisfactory. 3 In WLI mode, some lesions, such as EGC with a flat morphologic appearance or gastritis‐like EGC, may be missed because of low visibility. Various IEE techniques, such as narrow‐band imaging, blue laser imaging, and i‐scan, have recently emerged with the ability to enhance microvascular contrast and resolve minute superficial patterns and color differences. 4 Although IEE techniques have yielded better detection rates of superficial head and neck and esophageal cancers in comparison with WLI, 5 early IEE images are often too dark in the stomach area, making them unsuitable for EGC screening. 6

Linked color imaging (LCI) (Fujifilm Co., Tokyo, Japan) is a newly developed IEE technique that yields images with enhanced brightness and visualization of red and whitish lesions during routine endoscopy. Linked color imaging has been shown to be more effective than WLI for detecting gastric neoplastic lesions, and may be an effective method for screening EGC. 7 , 8 Optical enhancement mode 2 (OE‐2) is another new IEE technology developed by the Pentax Corporation (Tokyo, Japan). The OE‐2 filter blocks unwanted light from the white‐light color spectrum (RGB) that is produced by the xenon lamp in a video processor, while allowing a red “narrow band” to pass through the filter together with the blue and green wavelengths. This approach allows improved visualization of the mucosal surface and vascular patterns and yields enhanced image brightness. Therefore, OE‐2 can be recommended for endoscopic screening of EGC, and a large‐sample study for verifying the effectiveness of OE‐2 in the detection of EGC is necessary.

To address this need, we designed a prospective multicenter randomized controlled trial to explore whether OE‐2 can improve the detection rate of neoplastic lesions in a high‐risk population.

MATERIALS AND METHODS

Study design

This study was designed as an open‐label, parallel (1:1), multicenter, randomized controlled trial and was conducted across 16 hospitals in China in accordance with the Declaration of Helsinki. The study protocol was designed by the Center for Clinical Epidemiology and Evidence‐based Medicine, Naval Military Medical University (6 June 2019). The trial recruitment period was from 1 July 2019 to 1 July 2021. No major changes to the study procedures or outcomes were made after trial commencement. This study was registered at clinical trials.gov (NCT04720521) and approved by the Ethics Committee of Changhai Hospital, Shanghai, China. All eligible patients provided written informed consent to participate. An independent efficacy and safety committee monitored patients' safety, adverse events, and progress during the trial.

Participants

The research participants belonged to a high‐risk population of gastric cancer patients. The definition of the high‐risk population was based on the “Expert Consensus on the Screening Process for EGC in China (2017, Shanghai)” and “Consensus on Screening and Endoscopic Diagnosis and Treatment of EGC in China (2014, Changsha)”. 9 , 10 The inclusion criteria were as follows: age ≥40 years, no EGD examination for more than 2 years, and meeting one of the following conditions: (1) living in the areas with a high incidence of gastric cancer 11 ; (2) first‐degree relatives with gastric cancer; (3) relevant medical history, including chronic atrophic gastritis, gastric polyps, giant hypertrophic gastritis, gastric stump after subtotal gastrectomy, gastric ulcers and chronic anemia; (4) other risk factors for gastric cancer, such as diet with a high level of salt preservatives, smoking, and heavy drinking.

The exclusion criteria were as follows: major psychiatric disorders, abnormal coagulation function, contraindicated biopsy, prophylactic proton pump inhibitor treatment in the past 2 weeks, inability to tolerate endoscopy or cooperate with physicians, advanced cancer categorized as higher than the T2 stage under the TNM classification, and lack of informed patient consent.

Randomization

Using block randomization with a block size of four, patients were randomly assigned to the OE‐2 or WLI groups with stratification according to the center. The randomization list was generated with R software (version 3.5.1) by the Center for Clinical Epidemiology and Evidence‐based Medicine (Second Military Medical University/Naval Medical University), and it was placed in sealed opaque envelopes that were opened at the beginning of EGD. An independent researcher, who was not part of the endoscopy team, generated the allocation sequence and assigned participants to the groups.

EGD procedures

The endoscopic systems used in this study included EPK‐i7000 (Supplementary Figure S1) and upper gastrointestinal tract endoscopes (EG29‐i10 and EG‐2990ZI), all manufactured by Pentax Corporation, Japan.

All patients received the same mixture of 50 mL of water, 20,000 U of pronase (Tai De Pharmaceutical), and 10 mL of simethicone (5 g; Hong He, Pharmaceutical Co, Ltd.) before examination. All subjects received propofol‐based sedation administered by an anesthesiologist without endotracheal intubation under continuous monitoring for blood pressure, heart rate, and oxygen saturation. In the WLI group, the entire stomach was observed using the WLI system, and suspicious lesions were further evaluated with a biopsy. In the OE‐2 group, the system was switched to OE‐2 after withdrawal from the duodenum, and the entire stomach was observed by OE‐2. Suspicious lesions were further evaluated by biopsy. In this study, the endoscopists were required to have >3 years of IEE experience and had completed >2000 endoscopic examinations. OE‐experienced and inexperienced endoscopists were defined as those who had completed 100–300 or ＞300 OE mode procedures, respectively.

Pathological evaluation

Pathological diagnoses were made using biopsied tissue or resected specimens obtained from endoscopic resection or surgical removal. If both biopsied tissues and resected specimens were available, the final diagnosis was based on the latter. Neoplastic lesions were categorized as low‐grade intraepithelial neoplasia (LGIN), high‐grade intraepithelial neoplasia (HGIN), carcinoma, and adenoma. The diagnostic criteria for this categorization were based on the World Health Organization Classification of Digestive System Tumors.

Study end points

The primary end point was the diagnosis of 1 or more neoplastic lesions in the stomach. We also characterized all neoplastic lesions with respect to location, size, and morphologic characteristics.

Statistical analysis

Sample size

The detection rate of neoplastic lesions by WLI was 4.31% in a previous study. 7 Since the inclusion criteria of the study were similar to those in the previous study, we considered 4.31% to be the detection rate by WLI. Since no data for the detection rate of neoplastic lesions by OE‐2 have been published to date, we expected that the detection rate with OE‐2 would be similar to that achieved with other new IEE technologies reported previously7, resulting in a predicted detection rate of 8.01%. Thus, the sample size was initially calculated as 2454 patients, with 1227 patients per group, to achieve 80% power with a two‐sided alpha of 5%.

All statistical analyses were conducted using PASW Statistics for Windows software version 25.0 (SPSS, Inc.). Categorical data were presented as number of cases and percentage. Continuous data are reported as mean (SD). Statistical differences between groups were assessed using the χ 2 test, Fisher's exact test, Mann–Whitney U test, and Kruskal–Wallis H test for categorical data. A two‐sided p value of <0.05 was considered statistically significant in all tests.

RESULTS

Among the 1242 individuals initially included in the OE‐2 group, we excluded five and 26 individuals with advanced cancer and incomplete case report form (CRF) information, respectively, yielding a final population of 1211 individuals, of which three had multiple lesions. Among the 1268 individuals initially included in the WLI group, we excluded two and 47 individuals with advanced cancer and incomplete CRF information, respectively, yielding a final population of 1219 individuals (Figure 1). Before the analysis, both groups were checked for differences in terms of baseline information including age, sex, residence in areas with a high incidence of gastric cancer, history of gastric disease, presence of first‐degree relatives with gastric cancer, other risk factors for gastric cancer, and the OE‐2 experience level of endoscopists (Table 1).

An external file that holds a picture, illustration, etc. Object name is UEG2-12-772-g001.jpg

Flowchart showing recruitment of patients in this study.

TABLE 1

Basic information of the study participants in the OE‐2 group and the white‐light imaging (WLI) group.

OE‐2 group N = 1211WLI group N = 1219 p‐value
Age (years)58.4 ± 8.358.2 ± 8.50.672
Gender0.830
Male650 (53.7%)649 (53.2%)
Female561 (46.3%)570 (46.8%)
From areas with high incidence of gastric cancer0.086
Yes366 (30.2%)330 (27.1%)
No845 (69.8%)889 (72.9%)
History of gastric diseases0.735
Chronic atrophic gastritis128 (10.6%)127 (10.4%)
Gastric polyps82 (6.8%)85 (7.0%)
Gastric ulcers85 (7.0)77 (6.3%)
Chronic anemia4 (0.3%)3 (0.2%)
Giant hypertrophic gastritis3 (0.2%)3 (0.2%)
First‐degree relatives with gastric cancer0.547
Yes88 (7.3%)81 (6.6%)
No1123 (92.7%)1138 (93.4%)
With other risk factors for gastric cancer0.949
Yes451 (37.2%)492 (40.4%)
No760 (62.8%)727 (59.6%)
Endoscopists0.308
OE‐experienced486 (40.1%)514 (42.2%)
OE‐inexperienced725 (59.9%)705 (57.8%)

Next, we compared the detection rates of neoplastic lesions in the OE‐2 and WLI groups and the detection rate in the OE‐2 group (5.1%; 59/1211) was significantly higher than that in the WLI group (1.9%; 23/1219; p < 0.001; risk ratio [95% confidence interval], 2.656 [1.630–4.330]; Table 2). The median procedure time in both groups was 8 min, the range was 5–37 min, and there was no significant difference between OE‐2 group and WLI group (p = 0.290).

TABLE 2

Detection rate of neoplastic lesions between the OE‐2 group and the white‐light imaging (WLI) group.

Neoplastic lesionsOE‐2 groupWLI group p‐valueRR (95% CI)
Yes59 (5.1%)23 (1.9%)<0.0012.656 (1.630–4.330)
No1152 (94.9%)1196 (98.1%)

We also compared the differences in detection rates of neoplastic lesions with different gastric mucosal backgrounds. The detection rate of neoplastic lesions with an atrophic gastritis background in the OE‐2 group was significantly higher than that in the WLI group (9.3% vs. 2.6%, p < 0.001), but the two groups showed no significant difference in the detection rate of lesions with non‐atrophic gastritis (Table 3).

TABLE 3

Comparison of detection rates between the OE‐2 and white‐light imaging (WLI) groups of various background mucosa and endoscopist experience.

OE‐2 groupWLI group p‐value
Background mucosa
Atrophic gastritis<0.001
Neoplastic lesions37 (9.3%)10 (2.6%)
Non‐neoplastic lesions360 (90.7%)377 (97.4%)
Non‐atrophic gastritis0.111
Neoplastic lesions22 (2.7%)13 (1.6%)
Non‐neoplastic lesions795 (97.3%)819 (98.4%)
Endoscopist experience
OE‐experienced0.006
Neoplastic lesions22 (4.5%)8 (1.6%)
Non‐neoplastic lesions465 (95.5%)506 (98.4%)
OE‐inexperienced0.003
Neoplastic lesions37 (5.1%)15 (2.1%)
Non‐neoplastic lesions690 (94.9%)690 (97.9%)

Next, we analyzed the differences in the detection rate of neoplastic lesions in relation to the OE‐experience level of the endoscopists. In both groups of endoscopists with different experiences, the detection rate of neoplastic lesions in the OE‐2 group was higher than that in the WLI group (p = 0.006 and p = 0.003, respectively) (Table 3).

For the analysis of the detection rates in relation to lesion features, special lesions were compared with non‐neoplastic and other lesions. Since three patients in the OE‐2 group had multiple lesions, the total number of non‐neoplastic and neoplastic lesions was 1214. In our analysis of the detection rates of specific neoplastic lesions, including adenomas, LGIN and HGIN, and adenocarcinomas, the two groups showed no significant differences in the detection rates of adenomas and LGIN lesions, but the OE‐2 group showed significantly higher detection rates of HGIN lesions (1.0% vs. 0.3%; p = 0.044) and adenocarcinomas (1.2% vs. 0.0%; p < 0.001; Table 4).

TABLE 4

Comparison of detection rates between the OE‐2 and white‐light imaging (WLI) groups on various pathological characteristics.

Pathological characteristicsOE‐2 groupWLI group p‐value
Pathological diagnosisAdenoma7 (0.6%)4 (0.3%)0.361
LGIN25 (2.1%)15 (1.2%)0.108
HGIN12 (1.0%)4 (0.3%)0.044
Adenocarcinoma15 (1.2%)0 (0.0%)<0.001
Lesion locationCardia and fundus11 (0.9%)3 (0.2%)0.031
Gastric body12 (1.0%)2 (0.2%)0.007
Angulus8 (0.7%)2 (0.2%)0.112
Antrum28 (2.3%)16 (1.3%)0.066
Morphologic typeType 0‐II a20 (1.6%)8 (0.7%)0.022
Type 0‐II b18 (1.5%)8 (0.7%)0.047
Type 0‐II c14 (1.2%)6 (0.5%)0.071
Type 0‐II c + II a7 (0.6%)1 (0.1%)0.076
Lesion size≤1.0 cm37 (3.0%)15 (1.2%)0.002
1.1–2.0 cm18 (1.5%)7 (0.6%)0.026
＞2.0 cm4 (0.3%)1 (0.1%)0.368
Color Whitish 11 (0.9%)3 (0.2%)0.031
Isochromatic 13 (1.1%)2 (0.2%)0.004
Reddish 35 (2.9%)18 (1.5%)0.017

Abbreviations: HGIN, high‐grade intraepithelial neoplasia; LGIN, low‐grade intraepithelial neoplasia.

Next, we analyzed the lesion‐detection capability of OE‐2 and WLI for different locations. While the OE‐2 group showed higher lesion‐detection rates in the cardia and fundus (0.9% vs. 0.2%; p = 0.031) as well as the gastric body (1.0% vs. 0.2%; p = 0.007), the two groups showed no significant difference in the lesion‐detection rates in the angulus and antrum (Table 4).

We further analyzed whether the lesion‐detection rates of OE‐2 and WLI differed in relation to lesion morphologies. The OE‐2 group showed significantly higher detection rates for type 0‐IIa lesions (1.6% vs. 0.7%; p = 0.022) and type 0‐IIb lesions (1.5% vs. 0.7%; p = 0.047), but the detection rates for Type 0‐IIc and Type 0‐IIc + IIa lesions did not differ significantly between the groups (Table 4).

We then evaluated the differences in detection rates in relation to lesion sizes. The OE‐2 group showed significantly higher detection rates for lesions ≤1.0 cm (3.0% vs. 1.2%; p = 0.002), and for lesions 1.1–2.0 cm in size (0.3% vs. 0.1%; p = 0.026), but the two groups showed no significant difference in the detection rate of lesions >2.0 cm (Table 4).

Finally, the detection rates in different color tones of neoplastic lesions were also analyzed. The results showed that no matter the lesion was whitish, isochromatic, or reddish, the detection rates in OE‐2 group were higher than that in the WLI group (Table 4).

DISCUSSION

This was the first prospective multicenter study to explore whether OE‐2 can improve the detection rate of neoplastic lesions in a high‐risk population. The findings indicated that OE‐2 yielded significantly higher detection rates than WLI for neoplastic lesions. OE‐2 was also more advantageous in detecting lesions with atrophic gastritis in the background mucosa.

Despite the importance of EGD for detecting neoplastic lesions, WLI shows unsatisfactory sensitivity for EGC detection. ESGE guidelines in 2019 also pointed out that endoscopy with chromoendoscopy was better than WLI endoscopy alone for the diagnosis of gastric precancerous conditions or early neoplastic lesions. 12 Traditional IEE images are too dark in the stomach area to screen EGC. In this context, novel IEE technologies that can enhance brightness and improve the chromatic aberration between lesions and the normal mucosa can be more effective than WLI for detecting gastric neoplastic lesions, making them effective methods for screening EGC. 7 The OE technology is an IEE‐based technique developed by the Pentax Corporation that employs two modes with different OE filters (Mode 1 and Mode 2) and is designed mainly to improve the visualization of microvessels and enhance the contrast between vessels in superficial layers and those in the deep layers (Supplementary Figure S2). In OE‐2, however, the main R wavelength of the RGB signal (red light) is added to increase the overall brightness of the image, maintaining contrast while increasing the brightness of images 13 ; therefore, it is recommended for screening and detecting suspicious lesions (Figure 2).

An external file that holds a picture, illustration, etc. Object name is UEG2-12-772-g003.jpg

Typical pictures of early cancer under white‐light imaging and OE‐2 mode.

To our knowledge, no previous study has verified the screening capability of OE‐2. Only one small‐sample study evaluated the clinical utility of OE imaging (OE‐1 and OE‐2) by quantitatively evaluating the diagnostic performance in superficial esophageal squamous cell carcinoma. 14 The results showed that in comparison with WLI, all OE models exhibited significant additional effects on the [increment]E94 color difference. Therefore, OE images are also expected to be useful for the detection and characterization of tumors in the stomach and colon. Our findings support these speculations. Furthermore, while the difficulty of detecting suspicious lesions increases with atrophic gastritis, in the present study, the OE‐2 group showed a significantly better detection rate than the WLI group for lesions with an atrophic gastritis background. However, this difference was not observed for lesions with a normal gastric mucosal background. The detection rate of OE‐2 was not affected by the color of the lesion; regardless of whether the lesion was whitish, isochromatic, or reddish, the detection rates in OE‐2 group were higher than that in the WLI group. Nevertheless, no previous study has evaluated the color and brightness differences between OE‐2 images and WLI, and a more in‐depth comparison of OE‐2 image characteristics with the WLI mode is required in this regard.

Ono et al. showed that the diagnostic rate of neoplastic lesions was 8.0% in the LCI group and 4.8% in the WLI group, 8 which were obviously higher than the corresponding values in our study. One reason for these differences could be the use of different inclusion criteria, since Ono et al. included patients with known previous or current cancer of the GI tract. Moreover, Ono et al. included neoplastic lesions of the stomach as well as pharyngeal and esophageal neoplastic lesions. Another study that evaluated the detection rate of neoplastic lesions by LCI also showed higher diagnostic rates. 7  Although the inclusion criteria in this study were similar to those in our study, the participants were from different regions of China. This factor may have influenced the results since the incidence rate of gastric cancer differs across various regions of China. Although these results may also be attributable to differences between different endoscopic systems, no study has compared the diagnostic value of LCI with OE‐2 to date.

This study had some limitations. First, we did not record the patients' Helicobacter pylori (Hp) infection status. Hp infection is one of the risk factors for gastric carcinogenesis, and after eradicating Hp, some EGCs exhibit a gastritis‐like appearance, increasing the difficulty of endoscopic screening. Thus, differences in the Hp infection rate and infection status may influence the detection rate of endoscopic screening. Second, we classified LGIN as neoplastic lesions, similar to a previous study. 7 However, other studies have not classified LGIN as neoplastic lesions. 15 In one recent study, some of the gastric lesions diagnosed as LGIN by endoscopic biopsy remained unchanged during follow‐up, while others progressed to HGIN or adenocarcinoma. 16 Unfortunately, we did not follow‐up the patients who were diagnosed as showing LGIN by endoscopic biopsy, and the absence of the data for their outcomes may have introduced bias in the results. However, even after excluding the patients with LGIN, the detection rates in the OE‐2 group remained significantly higher than those in the WLI group (2.8% vs. 0.7%, p < 0.001). Third, open‐label design could introduce bias, and blinding is recommended to minimize the above bias. However, in this study, blinded outcome assessment was not feasible because the endoscopists, also as assessors, performed a real‐time assessment.

In conclusion, this large‐scale randomized comparative study demonstrated that OE‐2 was more effective than the traditional method in detecting neoplastic lesions in the stomach, highlighting its potential as a screening method for EGC that should be applied in clinical practice.

AUTHOR CONTRIBUTIONS

Conception and design: Zhao‐Shen Li, Dong Wang and Liang‐Hao Hu; analysis and interpretation of the data: Wei An; drafting of the article: Wei An; critical revision of the article for important intellectual content: Liang‐Hao Hu; endoscopic procedures and data collection: Qi Wu, Xiao‐Ju Su, Hong‐Xin Sun, Jing Wang, Wei‐Jia Dou, Zhen‐Xiong Liu, Gai‐Fang Liu, Yue‐Han Zhang, Shu‐Chang Xu, Ying Chen, Hao Zhang, Bin Zhang, Ping Li, Si‐Yu Sun, Sheng Wang, Wen Liu, Xiao‐Feng Zhang, W‐G G, Yu‐Shu Zhang, Yi‐Jun Xu, Mei Liu, Xin‐Xia Feng, Xiu‐Li Zuo, Guang‐Chao Li, K‐K L, Li‐Dong Xu and Xin‐Gang Shi.

CONFLICT OF INTEREST STATEMENT

The authors declare that they have no conflicts of interest for this article.

Supporting information

Supporting Information S1

Supporting Information S2

Figure S1

Figure S2

ACKNOWLEDGMENTS

We thank Professor Wei‐Gang Gu (Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China), Professor Xin‐Kai Zhao (Department of Gastroenterology, Hainan Cancer Hospital, Haikou, China), Professor Kun‐Kun Li (Department of Gastroenterology, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, China), Professor You‐Xiang Chen and Professor Hui‐Fang Xiong (Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, China), Professor Yong‐Jian Zhou and Professor Yong‐Qiang Li (Department of Gastroenterology and Hepatology, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China), and Professor Jian Song (Department of Gastroenterology, Southern University of Science and Technology Hospital, Shenzhen, China) for their support with the endoscopic procedures and data collection. Supported by Pentax Corporation.

Notes

An W, Wu Q, Su X‐J, Sun H‐X, Wang J, Dou W‐J, et al. Optical enhancement mode 2 improves the detection rate of gastric neoplastic lesion in high‐risk populations: a multicenter randomized controlled clinical study. United European Gastroenterol J. 2024;12(6):772–9. 10.1002/ueg2.12577 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]

Wei An, Qi Wu, Xiao‐Ju Su and Hong‐Xin Sun have contributed equally to this work.

Contributor Information

Dong Wang, [email protected].

Xin‐Gang Shi, moc.anis@gxihs_rd.

Liang‐Hao Hu, moc.liamtoh@uh-oahgnail.

Zhao‐Shen Li, moc.liamtoh@il-nehsoahz.

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are openly available in the United European Gastroenterology Journal.

REFERENCES

1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: globocan estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. 10.3322/caac.21660 [Abstract] [CrossRef] [Google Scholar]
2. Sekiguchi M, Oda I, Matsuda T, Saito Y. Epidemiological trends and future perspectives of gastric cancer in eastern asia. Digestion. 2022;103(1):22–28. 10.1159/000518483 [Abstract] [CrossRef] [Google Scholar]
3. Xu H, Li W. Early detection of gastric cancer in China: progress and opportunities. Cancer Biol Med. 2022;19(12):1622–1628. 10.20892/j.issn.2095-3941.2022.0655 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
4. Jang JY. The past, present, and future of image‐enhanced endoscopy. Clin Endosc. 2015;48(6):466–475. 10.5946/ce.2015.48.6.466 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
5. Muto M, Minashi K, Yano T, Saito Y, Oda I, Nonaka S, et al. Early detection of superficial squamous cell carcinoma in the head and neck region and esophagus by narrow band imaging: a multicenter randomized controlled trial. J Clin Oncol. 2010;28(9):1566–1572. 10.1200/jco.2009.25.4680 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
6. Yoshida N, Doyama H, Yano T, Horimatsu T, Uedo N, Yamamoto Y, et al. Early gastric cancer detection in high‐risk patients: a multicentre randomised controlled trial on the effect of second‐generation narrow band imaging. Gut. 2021;70(1):67–75. 10.1136/gutjnl-2019-319631 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
7. Gao J, Zhang X, Meng Q, Jin H, Zhu Z, Wang Z, et al. Linked color imaging can improve detection rate of early gastric cancer in a high‐risk population: a multi‐center randomized controlled clinical trial. Dig Dis Sci. 2021;66(4):1212–1219. 10.1007/s10620-020-06289-0 [Abstract] [CrossRef] [Google Scholar]
8. Ono S, Kawada K, Dohi O, Kitamura S, Koike T, Hori S, et al. Linked color imaging focused on neoplasm detection in the upper gastrointestinal tract: a randomized trial. Ann Intern Med. 2021;174(1):18–24. 10.7326/m19-2561 [Abstract] [CrossRef] [Google Scholar]
9. Digestive Endoscopy Branch of Chinese Medical Association CEPCoCACA . Consensus on early gastric cancer screening and endoscopic diagnosis and treatment in China (2014, changsha). Chin J Gastroenterol. 2014;19:408–427. [Google Scholar]
10. National Digestive System Disease Clinical Medical Research Center DEBoCMA . Expert consensus on the screening process for early gastric cancer in China (2017, shanghai). Chin J Gastroenterol. 2018;23:92–96. [Google Scholar]
11. Wang W, Chen D, Sang Y, Chen C, Zhang Y, Mao Y, et al. Endoscopic resection versus esophagectomy for patients with small‐sized t1n0 esophageal cancer: a propensity‐matched study. Clin Res Hepatol Gastroenterol. 2021;45(3):101543. 10.1016/j.clinre.2020.09.004 [Abstract] [CrossRef] [Google Scholar]
12. Pimentel‐Nunes P, Libanio D, Marcos‐Pinto R, Areia M, Leja M, Esposito G, et al. Management of epithelial precancerous conditions and lesions in the stomach (maps ii): European society of gastrointestinal endoscopy (esge), European helicobacter and microbiota study group (ehmsg), European society of pathology (esp), and Sociedade Portuguesa de Endoscopia Digestiva (sped) guideline update 2019. Endoscopy. 2019;51(04):365–388. 10.1055/a-0859-1883 [Abstract] [CrossRef] [Google Scholar]
13. Nagao M, Nishikawa J, Ogawa R, Sasaki S, Nakamura M, Nishimura J, et al. Evaluation of the diagnostic ability of optical enhancement system in early gastric cancer demarcation. Gastroenterol Res Pract. 2016;2016:2439621–2439626. 10.1155/2016/2439621 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
14. Kodashima S, Fujishiro M, Ono S, Niimi K, Mochizuki S, Asada‐Hirayama I, et al. Evaluation of a new image‐enhanced endoscopic technology using band‐limited light for detection of esophageal squamous cell carcinoma. Dig Endosc. 2014;26(2):164–171. 10.1111/den.12108 [Abstract] [CrossRef] [Google Scholar]
15. Japanese Gastric Cancer A. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011;14(2):101–112. 10.1007/s10120-011-0041-5 [Abstract] [CrossRef] [Google Scholar]
16. Zou L, Jiang Q, Guo T, Wu X, Wang Q, Feng Y, et al. Endoscopic characteristics in predicting prognosis of biopsy‐diagnosed gastric low‐grade intraepithelial neoplasia. Chin Med J Engl. 2022;135(1):26–35. 10.1097/cm9.0000000000001637 [Europe PMC free article] [Abstract] [CrossRef] [Google Scholar]
Articles from United European Gastroenterology Journal are provided here courtesy of Wiley

Full text links 

Read article at publisher's site: https://doi.org/10.1002/ueg2.12577

Read article for free, from open access legal sources, via Unpaywall: https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ueg2.12577Unpaywall

Citations & impact 

Impact metrics

2
Citations
Jump to Citations

Alternative metrics

Altmetric item for https://www.altmetric.com/details/163505610
Altmetric
Discover the attention surrounding your research
https://www.altmetric.com/details/163505610

Article citations

Data 

Data behind the article

This data has been text mined from the article, or deposited into data resources.

Clinical Trials

Similar Articles 

To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation.

Funding 

Funders who supported this work.

Pentax Corporation