Deep learning-based clinical decision support system for gastric neoplasms in real-time endoscopy: development and validation study.

BACKGROUND : Deep learning models have previously been established to predict the histopathology and invasion depth of gastric lesions using endoscopic images. This study aimed to establish and validate a deep learning-based clinical decision support system (CDSS) for the automated detection and classification (diagnosis and invasion depth prediction) of gastric neoplasms in real-time endoscopy. METHODS : The same 5017 endoscopic images that were employed to establish previous models were used for the training data. The primary outcomes were: (i) the lesion detection rate for the detection model, and (ii) the lesion classification accuracy for the classification model. For performance validation of the lesion detection model, 2524 real-time procedures were tested in a randomized pilot study. Consecutive patients were allocated either to CDSS-assisted or conventional screening endoscopy. The lesion detection rate was compared between the groups. For performance validation of the lesion classification model, a prospective multicenter external test was conducted using 3976 novel images from five institutions. RESULTS : The lesion detection rate was 95.6 % (internal test). On performance validation, CDSS-assisted endoscopy showed a higher lesion detection rate than conventional screening endoscopy, although statistically not significant (2.0 % vs. 1.3 %; P = 0.21) (randomized study). The lesion classification rate was 89.7 % in the four-class classification (advanced gastric cancer, early gastric cancer, dysplasia, and non-neoplastic) and 89.2 % in the invasion depth prediction (mucosa confined or submucosa invaded; internal test). On performance validation, the CDSS reached 81.5 % accuracy in the four-class classification and 86.4 % accuracy in the binary classification (prospective multicenter external test). CONCLUSIONS : The CDSS demonstrated its potential for real-life clinical application and high performance in terms of lesion detection and classification of detected lesions in the stomach.

Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial.

BACKGROUND: Owing to its strong acid inhibition, potassium-competitive acid blocker (P-CAB) based regimens for Helicobacter pylori (H. pylori) eradication are expected to offer clinical advantages over proton pump inhibitor (PPI) based regimens. This study aims to compare the efficacy and adverse effects of a 7-day and a 14-day P-CAB-based bismuth-containing quadruple regimen (PC-BMT) with those of a 14-day PPI-based bismuth-containing quadruple regimen (P-BMT) in patients with high clarithromycin resistance. METHODS: This randomized multicenter controlled clinical trial will be performed at five teaching hospitals in Korea. Patients with H. pylori infection who are naive to treatment will be randomized into one of three regimens: 7-day or 14-day PC-BMT (tegoprazan 50 mg BID, bismuth subcitrate 300 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or 14-day P-BMT. The eradication rate, treatment-related adverse events, and drug compliance will be evaluated and compared among the three groups. Antibiotic resistance testing by culture will be conducted during the trial, and these data will be used to interpret the results. A total of 366 patients will be randomized to receive 7-day PC-BMT (n = 122), 14-day PC-BMT (n = 122), or 14-day P-BMT (n = 122). The H. pylori eradication rates in the PC-BMT and P-BMT groups will be compared using intention-to-treat and per-protocol analyses. DISCUSSION: This study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration. TRIAL REGISTRATION: Korean Clinical Research Information Service registry, KCT0007444. Registered on 28 June 2022, https://cris.nih.go.kr/cris/index/index.do .

Is it enough to observe less than 2 cm sized gastric SET?

BACKGROUND AND AIMS: The recent surge in demand for screening endoscopy has led to an increased detection of gastric subepithelial tumors (SETs). According to current guideline, SETs less than 2 cm in size are recommended for periodic surveillance. In light of recent advancement in therapeutic endoscopy in resection of small SET, we analyzed the histopathological features and the effectiveness of endoscopic resection for these small SETs. METHODS: Retrospectively study was performed on 74 patients who underwent endoscopic resection of gastric small (≤ 2 cm) upper gastrointestinal tract SETs. The outcomes including histopathology and en bloc resection were analyzed. RESULTS: The mean SET size was 11.69 ± 5.11 mm. The mean procedure time was 81.26 ± 42.53 min. Of the 74 patients, 28 patients had leiomyomas, 26 had gastrointestinal stromal tumors (GISTs), 14 had ectopic pancreas, 4 had lipomas, and 2 had neuroendocrine tumors. Among those with GIST, two patients exhibited high-risk histology. All patients underwent successful and uneventful endoscopy. CONCLUSIONS: Endoscopic resection can be recommended even for the small gastric SETs. In our study, we found that SETs with a size of less than 2 cm have significant proportion of GISTs which harbor malignant transformation potential.

Clinical Decision Support System for All Stages of Gastric Carcinogenesis in Real-Time Endoscopy: Model Establishment and Validation Study.

BACKGROUND: Our research group previously established a deep-learning-based clinical decision support system (CDSS) for real-time endoscopy-based detection and classification of gastric neoplasms. However, preneoplastic conditions, such as atrophy and intestinal metaplasia (IM) were not taken into account, and there is no established model that classifies all stages of gastric carcinogenesis. OBJECTIVE: This study aims to build and validate a CDSS for real-time endoscopy for all stages of gastric carcinogenesis, including atrophy and IM. METHODS: A total of 11,868 endoscopic images were used for training and internal testing. The primary outcomes were lesion classification accuracy (6 classes: advanced gastric cancer, early gastric cancer, dysplasia, atrophy, IM, and normal) and atrophy and IM lesion segmentation rates for the segmentation model. The following tests were carried out to validate the performance of lesion classification accuracy: (1) external testing using 1282 images from another institution and (2) evaluation of the classification accuracy of atrophy and IM in real-world procedures in a prospective manner. To estimate the clinical utility, 2 experienced endoscopists were invited to perform a blind test with the same data set. A CDSS was constructed by combining the established 6-class lesion classification model and the preneoplastic lesion segmentation model with the previously established lesion detection model. RESULTS: The overall lesion classification accuracy (95% CI) was 90.3% (89%-91.6%) in the internal test. For the performance validation, the CDSS achieved 85.3% (83.4%-97.2%) overall accuracy. The per-class external test accuracies for atrophy and IM were 95.3% (92.6%-98%) and 89.3% (85.4%-93.2%), respectively. CDSS-assisted endoscopy showed an accuracy of 92.1% (88.8%-95.4%) for atrophy and 95.5% (92%-99%) for IM in the real-world application of 522 consecutive screening endoscopies. There was no significant difference in the overall accuracy between the invited endoscopists and established CDSS in the prospective real-clinic evaluation (P=.23). The CDSS demonstrated a segmentation rate of 93.4% (95% CI 92.4%-94.4%) for atrophy or IM lesion segmentation in the internal testing. CONCLUSIONS: The CDSS achieved high performance in terms of computer-aided diagnosis of all stages of gastric carcinogenesis and demonstrated real-world application potential.

Correction: Computer-Aided Diagnosis of Gastrointestinal Ulcer and Hemorrhage Using Wireless Capsule Endoscopy: Systematic Review and Diagnostic Test Accuracy Meta-analysis.

[This corrects the article DOI: 10.2196/33267.].

Computer-aided diagnosis of esophageal cancer and neoplasms in endoscopic images: a systematic review and meta-analysis of diagnostic test accuracy.

BACKGROUND AND AIMS: Diagnosis of esophageal cancer or precursor lesions by endoscopic imaging depends on endoscopist expertise and is inevitably subject to interobserver variability. Studies on computer-aided diagnosis (CAD) using deep learning or machine learning are on the increase. However, studies with small sample sizes are limited by inadequate statistical strength. Here, we used a meta-analysis to evaluate the diagnostic test accuracy (DTA) of CAD algorithms of esophageal cancers or neoplasms using endoscopic images. METHODS: Core databases were searched for studies based on endoscopic imaging using CAD algorithms for the diagnosis of esophageal cancer or neoplasms and presenting data on diagnostic performance, and a systematic review and DTA meta-analysis were performed. RESULTS: Overall, 21 and 19 studies were included in the systematic review and DTA meta-analysis, respectively. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD algorithms for the diagnosis of esophageal cancer or neoplasms in the image-based analysis were 0.97 (95% confidence interval [CI], 0.95-0.99), 0.94 (95% CI, 0.89-0.96), 0.88 (95% CI, 0.76-0.94), and 108 (95% CI, 43-273), respectively. Meta-regression showed no heterogeneity, and no publication bias was detected. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD algorithms for the diagnosis of esophageal cancer invasion depth were 0.96 (95% CI, 0.86-0.99), 0.90 (95% CI, 0.88-0.92), 0.88 (95% CI, 0.83-0.91), and 138 (95% CI, 12-1569), respectively. CONCLUSIONS: CAD algorithms showed high accuracy for the automatic endoscopic diagnosis of esophageal cancer and neoplasms. The limitation of a lack in performance in external validation and clinical applications should be overcome.

Computer-Aided Diagnosis of Gastrointestinal Ulcer and Hemorrhage Using Wireless Capsule Endoscopy: Systematic Review and Diagnostic Test Accuracy Meta-analysis.

BACKGROUND: Interpretation of capsule endoscopy images or movies is operator-dependent and time-consuming. As a result, computer-aided diagnosis (CAD) has been applied to enhance the efficacy and accuracy of the review process. Two previous meta-analyses reported the diagnostic performance of CAD models for gastrointestinal ulcers or hemorrhage in capsule endoscopy. However, insufficient systematic reviews have been conducted, which cannot determine the real diagnostic validity of CAD models. OBJECTIVE: To evaluate the diagnostic test accuracy of CAD models for gastrointestinal ulcers or hemorrhage using wireless capsule endoscopic images. METHODS: We conducted core databases searching for studies based on CAD models for the diagnosis of ulcers or hemorrhage using capsule endoscopy and presenting data on diagnostic performance. Systematic review and diagnostic test accuracy meta-analysis were performed. RESULTS: Overall, 39 studies were included. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD models for the diagnosis of ulcers (or erosions) were .97 (95% confidence interval, .95-.98), .93 (.89-.95), .92 (.89-.94), and 138 (79-243), respectively. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD models for the diagnosis of hemorrhage (or angioectasia) were .99 (.98-.99), .96 (.94-0.97), .97 (.95-.99), and 888 (343-2303), respectively. Subgroup analyses showed robust results. Meta-regression showed that published year, number of training images, and target disease (ulcers vs erosions, hemorrhage vs angioectasia) was found to be the source of heterogeneity. No publication bias was detected. CONCLUSIONS: CAD models showed high performance for the optical diagnosis of gastrointestinal ulcer and hemorrhage in wireless capsule endoscopy.

Computer-Aided Diagnosis of Diminutive Colorectal Polyps in Endoscopic Images: Systematic Review and Meta-analysis of Diagnostic Test Accuracy.

BACKGROUND: Most colorectal polyps are diminutive and benign, especially those in the rectosigmoid colon, and the resection of these polyps is not cost-effective. Advancements in image-enhanced endoscopy have improved the optical prediction of colorectal polyp histology. However, subjective interpretability and inter- and intraobserver variability prohibits widespread implementation. The number of studies on computer-aided diagnosis (CAD) is increasing; however, their small sample sizes limit statistical significance. OBJECTIVE: This review aims to evaluate the diagnostic test accuracy of CAD models in predicting the histology of diminutive colorectal polyps by using endoscopic images. METHODS: Core databases were searched for studies that were based on endoscopic imaging, used CAD models for the histologic diagnosis of diminutive colorectal polyps, and presented data on diagnostic performance. A systematic review and diagnostic test accuracy meta-analysis were performed. RESULTS: Overall, 13 studies were included. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD models for the diagnosis of diminutive colorectal polyps (adenomatous or neoplastic vs nonadenomatous or nonneoplastic) were 0.96 (95% CI 0.93-0.97), 0.93 (95% CI 0.91-0.95), 0.87 (95% CI 0.76-0.93), and 87 (95% CI 38-201), respectively. The meta-regression analysis showed no heterogeneity, and no publication bias was detected. Subgroup analyses showed robust results. The negative predictive value of CAD models for the diagnosis of adenomatous polyps in the rectosigmoid colon was 0.96 (95% CI 0.95-0.97), and this value exceeded the threshold of the diagnosis and leave strategy. CONCLUSIONS: CAD models show potential for the optical histological diagnosis of diminutive colorectal polyps via the use of endoscopic images. TRIAL REGISTRATION: PROSPERO CRD42021232189; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=232189.

The number of wire placement in the pancreatic duct and metal biliary stent as risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND AND AIM: Many post-ERCP pancreatitis (PEP) risk factors, including pancreatic duct cannulation, have been identified; however, whether the number of repeated and unintentional wire placements (WPs) in the pancreatic duct during wire-guided cannulation affects PEP risk is unknown. We aimed to identify the effects of repeated WP in the pancreatic duct and other potential risk factors on PEP incidence. METHODS: We retrospectively analyzed 877 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP). We examined potential patient-related and procedure-related risk factors, and PEP incidence by univariable and multivariable logistic regression analyses. RESULTS: Thirty-four patients (3.9%) had PEP. Univariable analysis revealed younger age, malignant common bile duct or ampulla of Vater stricture, two or more episodes of WPs in the pancreatic duct, and metal biliary stent as risk factors for PEP. Following multivariable analysis, two or more episodes of WPs in the pancreatic duct and metal biliary stent remained in the final model. PEP did not increase significantly in case of a one episode of WP (4.0%) compared with no episode of WP in the pancreatic duct (2.7%). However, patients with two episodes of WPs had 8.0% incidence and three or more episodes of WPs had 14.3%. CONCLUSIONS: A WP in the pancreatic duct and a metal biliary stent were associated with increased PEP incidence in patients undergoing ERCP. As for the pancreatic duct wire cannulation, two or more WPs considerably increased PEP incidence. This suggests that preventive measures or alternative procedures might be considered in patients with such cases during and after ERCP.

Endoscopic Submucosal Dissection of Early Gastric Cancer with Mixed-Type Histology: A Systematic Review.

BACKGROUND: Endoscopic submucosal dissection (ESD) criteria are histologically categorized by early gastric cancer (EGC) with differentiated- and undifferentiated-type histology. However, EGC is histologically heterogenous and there have been no separate criteria for EGC with mixed-type histology [EGC-MH; differentiated-type predominant EGC mixed with an undifferentiated component (EGC-MD) or undifferentiated-type predominant EGC mixed with a differentiated component (EGC-MU)]. Moreover, therapeutic outcomes of ESD for EGC-MH have not been clearly described. AIM: This study aimed to evaluate the feasibility of ESD for EGC-MH. METHODS: We searched core databases for specific inclusion factors: patients with EGC-MH, intervention of ESD, and at least one of the following outcomes: rate of en bloc, complete, curative resection, recurrence, procedure-related adverse event, lymphovascular invasion (LVI), or lymph node metastasis (LNM) that enabled evaluation of feasibility of ESD. RESULTS: A total of eight (systematic review) and four studies (meta-analysis) were included. There was no robustness in age, location, or morphology of EGC-MH. Moderately differentiated adenocarcinoma was frequent in pre-ESD biopsy. EGC-MH showed larger size, deeper invasion, and higher rates of LVI/LNM than pure-type EGC. Total en bloc, complete resection, and curative resection rates were 94.6% (95% confidence interval 86.6-97.9%), 77.8% (57.9-89.9%), and 55.1% (50.4-59.6%), respectively. There was no LNM or extra-gastric recurrence after ESD if the EGC-MD met the curative resection criteria. However, the EGC-MD itself was a risk factor for non-curative resection. (Margin positivity was the most common reason.) CONCLUSIONS: Although ESD seems to be technically feasible, inaccurate prediction of lateral or vertical margin leads to lower curative resection rate. Application of more strict indication is needed for EGC-MH.

Ambient air pollution in gastrointestinal endoscopy unit.

BACKGROUND: The gastrointestinal endoscopy unit is frequently exposed to gastrointestinal gas expelled from patients and electrocoagulated tissue through carbonation. This can be potentially harmful to the health of not only the healthcare personnel but also patients who undergo endoscopy. This study aimed to measure the air quality in the endoscopy unit. METHODS: We measured indoor air quality indices (CO2, total volatile organic compounds (VOCs), PM2.5, NO2, CO, and ozone) using portable passive air quality monitoring sensors in the procedural area, recovery area, and cleansing-of-equipment area, at 1-min intervals for 1 week, and the type and number of endoscopic procedures were recorded. RESULTS: CO2, PM2.5, NO2, and ozone levels were the highest in the cleansing area, followed by the procedural and recovery areas, and VOC level was highest in the procedural area. The proportion of poor-quality level of CO2 and VOCs was highest in the procedural area and that of NO2 was highest in the cleansing area. The proportion of tolerable to poor-quality (exceeding acceptable level) level of CO2 and total VOCs in the procedural area was 26% and 19.2% in all measurement times, respectively. The proportion of tolerable to poor-quality level of NO2 in the cleansing area of the endoscopy unit was 32.1% in all measurement times. Multivariate analyses revealed that tolerable to poor-quality (exceeding acceptable level) level of VOCs was associated with the number of endoscopic procedures (odds ratio, 1.79; 95% confidence interval, 1.42-2.27) and PM2.5 level (1.27, 1.12-1.44). Moreover, tolerable to poor-quality level of CO2 was associated with the number of colonoscopy (5.35, 1.19-24.02), especially with electrocoagulation procedures (24.31, 1.31-452.44) in the procedural area. CONCLUSIONS: Healthcare personnel and patients who undergo endoscopy are frequently exposed to ambient air pollution. Health-related protective strategies for ambient air pollution in the endoscopy unit are warranted. CLINICALTRIALS. GOV REGISTRATION NUMBER: NCT03724565.

Artificial Intelligence for the Prediction of Helicobacter Pylori Infection in Endoscopic Images: Systematic Review and Meta-Analysis Of Diagnostic Test Accuracy.

BACKGROUND: Helicobacter pylori plays a central role in the development of gastric cancer, and prediction of H pylori infection by visual inspection of the gastric mucosa is an important function of endoscopy. However, there are currently no established methods of optical diagnosis of H pylori infection using endoscopic images. Definitive diagnosis requires endoscopic biopsy. Artificial intelligence (AI) has been increasingly adopted in clinical practice, especially for image recognition and classification. OBJECTIVE: This study aimed to evaluate the diagnostic test accuracy of AI for the prediction of H pylori infection using endoscopic images. METHODS: Two independent evaluators searched core databases. The inclusion criteria included studies with endoscopic images of H pylori infection and with application of AI for the prediction of H pylori infection presenting diagnostic performance. Systematic review and diagnostic test accuracy meta-analysis were performed. RESULTS: Ultimately, 8 studies were identified. Pooled sensitivity, specificity, diagnostic odds ratio, and area under the curve of AI for the prediction of H pylori infection were 0.87 (95% CI 0.72-0.94), 0.86 (95% CI 0.77-0.92), 40 (95% CI 15-112), and 0.92 (95% CI 0.90-0.94), respectively, in the 1719 patients (385 patients with H pylori infection vs 1334 controls). Meta-regression showed methodological quality and included the number of patients in each study for the purpose of heterogeneity. There was no evidence of publication bias. The accuracy of the AI algorithm reached 82% for discrimination between noninfected images and posteradication images. CONCLUSIONS: An AI algorithm is a reliable tool for endoscopic diagnosis of H pylori infection. The limitations of lacking external validation performance and being conducted only in Asia should be overcome. TRIAL REGISTRATION: PROSPERO CRD42020175957; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=175957.

Automated classification of gastric neoplasms in endoscopic images using a convolutional neural network.

BACKGROUND: Visual inspection, lesion detection, and differentiation between malignant and benign features are key aspects of an endoscopist's role. The use of machine learning for the recognition and differentiation of images has been increasingly adopted in clinical practice. This study aimed to establish convolutional neural network (CNN) models to automatically classify gastric neoplasms based on endoscopic images. METHODS: Endoscopic white-light images of pathologically confirmed gastric lesions were collected and classified into five categories: advanced gastric cancer, early gastric cancer, high grade dysplasia, low grade dysplasia, and non-neoplasm. Three pretrained CNN models were fine-tuned using a training dataset. The classifying performance of the models was evaluated using a test dataset and a prospective validation dataset. RESULTS: A total of 5017 images were collected from 1269 patients, among which 812 images from 212 patients were used as the test dataset. An additional 200 images from 200 patients were collected and used for prospective validation. For the five-category classification, the weighted average accuracy of the Inception-Resnet-v2 model reached 84.6 %. The mean area under the curve (AUC) of the model for differentiating gastric cancer and neoplasm was 0.877 and 0.927, respectively. In prospective validation, the Inception-Resnet-v2 model showed lower performance compared with the endoscopist with the best performance (five-category accuracy 76.4 % vs. 87.6 %; cancer 76.0 % vs. 97.5 %; neoplasm 73.5 % vs. 96.5 %; P  < 0.001). However, there was no statistical difference between the Inception-Resnet-v2 model and the endoscopist with the worst performance in the differentiation of gastric cancer (accuracy 76.0 % vs. 82.0 %) and neoplasm (AUC 0.776 vs. 0.865). CONCLUSION: The evaluated deep-learning models have the potential for clinical application in classifying gastric cancer or neoplasm on endoscopic white-light images.

The most influential articles in Helicobacter pylori research: A bibliometric analysis.

OBJECTIVE: The number of articles that researchers must be familiar with is increasing, along with the importance of selective searching and summarization. This study aimed to assess and characterize the most influential articles in Helicobacter pylori research. METHODS: We performed a search of the top-100 cited articles using the Web of Science Core Collection (WoSCC) and Google Scholar from their inception to 2018. The top-100 Altmetric Attention Score (AAS) articles based on online media mentions were also searched using the term H pylori. Each article was evaluated for the following characteristics: citation number, title, journal, publication year, and authorship. RESULTS: The citation number for the top-100 WoSCC articles ranged from 44 to 367. Gut published the largest number of articles (11%). In the top-100 Google Scholar articles, Lancet had the largest number of articles (13%); however, among the top-1000 cited articles published after 2012, Helicobacter published the largest number (46%). The largest number of top-100 AAS articles was published by PLOS Pathogens (6%). PubMed Central articles' citations in WoSCC or Google Scholar showed significant correlation with those from each metric; however, AAS showed no correlation. The proportion of basic research was 36%-37% in top-cited articles; but, 52% in the top-100 AAS articles. No time trend in the number of publications or citations of basic/clinical research in the top-100 bibliometrics was found. "Meta-analysis/systematic review," "gastric cancer," "eradication," and "association" were the most influential title words. CONCLUSION: This study presents a detailed list of top-100 articles, journals, authors, and topic title words.

Nationwide antibiotic resistance mapping of Helicobacter pylori in Korea: A prospective multicenter study.

INTRODUCTION: The eradication rates for Helicobacter pylori have decreased in Korea although the prevalence of this bacterium has also decreased. Antibiotic resistance is likely to be a crucial factor in H. pylori eradication success, and we therefore mapped these resistance patterns nationwide in Korea. MATERIALS AND METHODS: Five hundred and ninety adult subjects were prospectively enrolled from 2017 to 2018 from 15 centers across six geographic areas of Korea. A total of 580 biopsy tissues had been sampled from these patients during an upper endoscopy and were frozen at -80°C and delivered to a central laboratory. The agar dilution method was used to determine the minimum inhibitory concentration of amoxicillin, clarithromycin, metronidazole, tetracycline, ciprofloxacin, and levofloxacin for each H. pylori isolate. RESULTS: The culture success rate was 60.2% (349/580). Resistance rates against clarithromycin, metronidazole, amoxicillin, tetracycline, levofloxacin, and ciprofloxacin were 17.8%, 29.5%, 9.5%, 0%, 37.0%, and 37.0%, respectively. The geographic distribution of metronidazole and quinolone resistance was highly variable. Some subjects had multiple H. pylori strains in the antrum and body of the stomach and showed a heterogeneous resistance profile between these anatomic areas. The H. pylori multidrug resistance (MDR) rate was 25.2% (88/349) among amoxicillin, clarithromycin, metronidazole, tetracycline, and quinolone and 11.2% (39/349) among four of these major antibiotics except for quinolone. The Seoul and Chungcheong areas showed a relatively lower MDR rate. CONCLUSION: The antibiotic resistance of H. pylori differs by drug and geographic area in Korea. Detailed nationwide antibiotic resistance mapping is needed to develop an effective H. pylori eradication strategy.

Online registry for nationwide database of Helicobacter pylori eradication in Korea: Correlation of antibiotic use density with eradication success.

BACKGROUND: The Helicobacter pylori eradication rate has decreased with increasing antibiotic resistance. We conducted a prospective, nationwide, multicenter registry study to monitor the real status of H. pylori eradication therapy and to investigate the association between eradication success and antibiotic use density in Korea. MATERIALS AND METHODS: We enrolled 9318 patients undergoing H. pylori eradication therapy from 37 hospitals through "on-line database registry" from October 2010 to July 2015. Demographic data, detection methods, treatment indications, regimens, durations, compliance, adverse events, and eradication results were collected. The use of all commercially available eradication antibiotics was analyzed through the Korean National Health Insurance data of the Health Insurance Review and Assessment Service. The defined daily dose of antibiotics was used to standardize drug use comparisons. RESULTS: Finally, 6738 patients were analyzed. The overall eradication rate of first-line therapy was 71.8%. The eradication success rates were 71.7%, 86.9%, and 74.0% for standard triple therapy for 7 days, quadruple therapy, and concomitant therapy, respectively. The eradication success rate in naive patients was higher than that in those who previously underwent H. pylori eradication. Eradication success was significantly associated with younger age, female sex, and high compliance. Regional differences in eradication rates were observed. The yearly use density of clarithromycin increased statistically in seven regions across the country from 2010 to 2015. The yearly use density of amoxicillin in the Gyeongsang and Chungcheong areas was significantly increased (P < .01), whereas that of other macrolides was significantly lower in the Gyeonggi area than in other areas (P = .01). The overall use of eradication antibiotics has increased while the eradication rate steadily decreased for 5 years. However, there was no significant correlation between antibiotic use density and eradication. CONCLUSION: There was no relationship between the eradication rate and antibiotic use density in Korea.

Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study.

BACKGROUND: The optimal treatment regimen or the duration of treatment for an endoscopic submucosal dissection (ESD)-induced gastric ulcer has not been established. The aim of this study was to assess the efficacy of novel proton-pump inhibitor, ilaprazole, for the treatment of ESD-induced gastric ulcer. METHODS: This was a prospective, open-label, randomized multicenter study. Between June 2015 and March 2018, a total of 176 patients (178 lesions) who underwent ESD for a gastric neoplasm were randomly allocated to receive the oral proton-pump inhibitor ilaprazole 20 mg or rabeprazole 20 mg daily for 8 weeks. The primary outcome was the ulcer healing rate at 4 and 8 weeks. RESULTS: A total of 155 (157 lesions) and 154 patients (156 lesions) were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks, 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis) or stage of ulcer (scar stage, 25.6% vs. 17.7%, p = 0.25 at 4 weeks, 92.3% vs. 88.6%, p = 0.59 at 8 weeks in the mITT analysis) between the treatment groups. The quality of ulcer healing was not significantly different between the two groups. No independent predictive factor for higher-quality ulcer healing was found in the multivariate analysis. CONCLUSIONS: According to this trial, ilaprazole and rabeprazole showed no significant difference in the healing of artificial gastric ulcers. Most of the ulcers achieved complete healing within 4-8 weeks. TRIAL REGISTRATION: ClinicalTrial.gov NCT02638584.

Positive Association Between Helicobacter pylori Infection and Metabolic Syndrome in a Korean Population: A Multicenter Nationwide Study.

BACKGROUND AND AIM: Helicobacter pylori (H. pylori) infection causes extra-gastrointestinal as well as gastric diseases. This analytical cross-sectional study was performed to investigate the association between H. pylori infection and metabolic syndrome in a Korean population. METHODS: Anthropometric and metabolic data, as well as anti-H. pylori IgG antibodies, were measured in 21,106 subjects who participated in a health checkup between January 2016 and June 2017. The classification of metabolic syndrome followed the revised National Cholesterol Education Program criteria. RESULTS: After excluding subjects with a history of H. pylori eradication therapy, or gastric symptoms, the seropositivity of H. pylori was 43.2% in 15,195 subjects. H. pylori-positive participants had significantly higher body mass index (BMI), waist circumference, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and lower high-density lipoprotein (HDL-C) than did seronegative participants (P < 0.05). After adjusting for confounders, high TC, low HDL-C, and high LDL-C were associated with H. pylori seropositivity. Finally, the prevalence of metabolic syndrome was higher in H. pylori-seropositive subjects than in negative ones (27.2% vs. 21.0%, P < 0.05), and H. pylori seropositivity increased the likelihood of metabolic syndrome (OR 1.19, 95% CI 1.09-1.31, P < 0.001) after adjusting for sex, age, BMI, smoking, residence, household income, and education level. However, the association between H. pylori seropositivity and metabolic syndrome disappeared in those ≥ 65 years old. CONCLUSIONS: H. pylori infection plays an independent role in the pathogenesis of metabolic syndrome in Koreans under 65 years old.

Seroprevalence of Helicobacter pylori in Korea: A multicenter, nationwide study conducted in 2015 and 2016.

BACKGROUND: The Korean College of Helicobacter and Upper Gastrointestinal Research has studied Helicobacter pylori (H. pylori) prevalence since 1998 and found a dynamic change in its prevalence in Korea. The aim of this study was to determine the recent H. pylori prevalence rate and compare it with that of previous studies according to socioeconomic variables. METHODS: We planned to enroll 4920 asymptomatic Korean adults from 21 centers according to the population distribution of seven geographic areas (Seoul, Gyeonggi, Gangwon, Chungcheong, Kyungsang, Cholla, and Jeju). We centrally collected serum and tested H. pylori serum IgG using a chemiluminescent enzyme immunoassay. RESULTS: We analyzed 4917 samples (4917/4920 = 99.9%) from January 2015 to December 2016. After excluding equivocal serologic results, the H. pylori seropositivity rate was 51.0% (2414/4734). We verified a decrease in H. pylori seroprevalence compared with previous studies performed in 1998, 2005, and 2011 (P < .0001). The H. pylori seroprevalence rate differed by area: Cholla (59.5%), Chungcheong (59.2%), Kyungsang (55.1%), Jeju (54.4%), Gangwon (49.1%), Seoul (47.4%), and Gyeonggi (44.6%). The rate was higher in those older than 40 years (38.1% in those aged 30-39 years and 57.7% in those aged 40-49 years) and was lower in city residents than in noncity residents at all ages. CONCLUSIONS: Helicobacter pylori seroprevalence in Korea is decreasing and may vary according to population characteristics. This trend should be considered to inform H. pylori-related policies.

Prevalence and risk factors for upper gastrointestinal diseases in health check-up subjects: a nationwide multicenter study in Korea.

OBJECTIVES: The prevalence of upper gastrointestinal disease is expected to change following advances in socioeconomic status and improved hygiene in Korea. The aim of this study was to investigate the recent trends in upper gastrointestinal diseases based on endoscopic findings and Helicobacter pylori (H. pylori) seroprevalence in subjects undergoing health check-up at tertiary centers in Korea. METHODS: A multicenter cross-sectional study was conducted at nine healthcare centers between September 2016 and June 2017. The subjects were evaluated using questionnaires, upper endoscopy and H. pylori serology tests. The results were compared with previous data in our study group obtained from eight tertiary healthcare centers in 2011 (n = 4023). RESULTS: In total, we prospectively enrolled 2504 subjects undergoing health check-up. The prevalence of reflux esophagitis (RE) was 9.7%, which showed an increasing but insignificant trend since 2011 (8.8%). The prevalence of active and healing-stage benign gastric ulcer and duodenal ulcer (DU) was 1.6% and 1.2%, respectively, which confirmed a significant decrease since 2011 (4.1%; p < .001 and 2.2%; p = .005, respectively). The prevalence of gastric cancer was 0.5%, representing an increasing trend since 2011 (0.12%; p = .003). H. pylori seroprevalence was 51.3%, which significantly decreased from 2011 (59.8%; p < .001). In multivariate analysis, H. pylori seropositivity was a significant risk factor for DU (p < .001), whereas a significant protective factor against RE (p < .001). CONCLUSIONS: The significant decrease of H. pylori seroprevalence in the past five years altered the incidence of upper gastrointestinal disease.