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 .

Impact of pitavastatin on new-onset diabetes mellitus compared to atorvastatin and rosuvastatin: a distributed network analysis of 10 real-world databases.

BACKGROUND: Statin treatment increases the risk of new-onset diabetes mellitus (NODM); however, data directly comparing the risk of NODM among individual statins is limited. We compared the risk of NODM between patients using pitavastatin and atorvastatin or rosuvastatin using reliable, large-scale data. METHODS: Data of electronic health records from ten hospitals converted to the Observational Medical Outcomes Partnership Common Data Model (n = 14,605,368 patients) were used to identify new users of pitavastatin, atorvastatin, or rosuvastatin (atorvastatin + rosuvastatin) for ≥ 180 days without a previous history of diabetes or HbA1c level ≥ 5.7%. We conducted a cohort study using Cox regression analysis to examine the hazard ratio (HR) of NODM after propensity score matching (PSM) and then performed an aggregate meta-analysis of the HR. RESULTS: After 1:2 PSM, 10,238 new pitavastatin users (15,998 person-years of follow-up) and 18,605 atorvastatin + rosuvastatin users (33,477 person-years of follow-up) were pooled from 10 databases. The meta-analysis of the HRs demonstrated that pitavastatin resulted in a significantly reduced risk of NODM than atorvastatin + rosuvastatin (HR 0.72; 95% CI 0.59-0.87). In sub-analysis, pitavastatin was associated with a lower risk of NODM than atorvastatin or rosuvastatin after 1:1 PSM (HR 0.69; CI 0.54-0.88 and HR 0.74; CI 0.55-0.99, respectively). A consistently low risk of NODM in pitavastatin users was observed when compared with low-to-moderate-intensity atorvastatin + rosuvastatin users (HR 0.78; CI 0.62-0.98). CONCLUSIONS: In this retrospective, multicenter active-comparator, new-user, cohort study, pitavastatin reduced the risk of NODM compared with atorvastatin or rosuvastatin.

Long-term proton pump inhibitor use and risk of osteoporosis and hip fractures: A nationwide population-based and multicenter cohort study using a common data model.

BACKGROUND AND AIM: Association between protonpump inhibitors (PPIs) and osteoporosis, hip fractures has not been fully elucidated. We aimed to evaluate the relationship between PPIs use and the risk of osteoporosis and hip fractures in the databases converted to a common data model (CDM) and to compare the results across the databases. METHODS: This was a population-based, propensity-matched, retrospective cohort study that included patients aged ≥ 50 years who were prescribed with PPIs for over 180 days. We compared the incidence of osteoporosis and hip fractures between new PPI user and new user of other drugs using the Cox proportional hazards model and performed meta-analysis in the electronic health record (EHR) databases. RESULTS: In the Korean National Health Insurance Service (NHIS)-CDM database, long-term PPI users had greater risk of osteoporosis [PPIs vs non-PPIs groups, 28.42/1000 person-years vs 19.29/1000 person-years; hazard ratio (HR), 1.62; 95% confidence interval (CI), 1.22-2.15; P = 0.001]. The meta-analytic results of six EHR databases also showed similar result (pooled HR, 1.57; 95% CI, 1.28-1.92). In the analysis of hip fracture, PPI use was not significantly associated with a hip fracture in the NHIS-CDM database (PPI vs non-PPI groups, 3.09/1000 person-years vs 2.26/1000 person-years; HR, 1.45; 95% CI, 0.74-2.80; P = 0.27). However, in the meta-analysis of four EHR databases, the risk of hip fractures was higher in PPI users (pooled HR, 1.82; 95% CI, 1.04-3.19). CONCLUSIONS: Long-term PPI was significantly associated with osteoporosis; however, the results of hip fractures were inconsistent. Further study based on better data quality may be needed.

Prediction model for curative endoscopic submucosal dissection of undifferentiated-type early gastric cancer.

BACKGROUND: Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer (EGC); however, its curative resection rate is low for undifferentiated-type EGC. We developed and externally validated a prediction model for curative ESD of undifferentiated-type EGC. METHODS: In this cross-sectional study, we included 448 patients who underwent ESD for undifferentiated-type EGC at 18 hospitals in Korea between 2005 and 2015 in the development cohort and 1342 patients who underwent surgery at two hospitals in the validation cohort. A prediction model was developed using the logistic regression model. RESULTS: Endoscopic tumor size 1-2 cm (odds ratio [OR], 2.40; 95% confidence interval [CI] 1.54-3.73), tumor size > 2 cm (OR, 14.00; 95% CI 6.81-28.77), and proximal tumor location from the lower to upper third of the stomach (OR, 1.45; 95% CI 1.03-2.04) were independent predictors of non-curative ESD. A six-score prediction model was developed by assigning points to endoscopic tumor size > 2 cm (five points), tumor size 1-2 cm (two points), upper third location (two points), and middle third location (one point). The rate of curative ESD ranged from 70.6% (score 0) to 11.6% (score 5) with an area under the receiver operating characteristic curve (AUC) of 0.720 (95% CI 0.673-0.766). The model also showed good performance in the validation cohort (AUC, 0.775; 95% CI 0.748-0.803). CONCLUSIONS: This six-score prediction model may help in predicting curative ESD and making informed decisions about the treatment selection between ESD and surgery for undifferentiated-type EGC.

Long-term outcomes of endoscopic resection followed by additional surgery after non-curative resection in undifferentiated-type early gastric cancer: a nationwide multi-center study.

BACKGROUND: Undifferentiated-type early gastric cancer (UD EGC) shows lower curative resection rates after endoscopic submucosal dissection (ESD). Additional surgery is recommended after non-curative resection. We evaluated the long-term outcomes of ESD followed by additional surgery after non-curative resection in UD EGC compared to those for surgery as initial treatment. METHODS: We reviewed 1139 UD EGC patients who underwent ESD at 18 hospitals and 1956 patients who underwent surgery at two hospitals between February 2005 and May 2015. We enrolled 636 patients with non-curative ESD and 1429 surgery subjects beyond the curative ESD criteria. Among them, 133 patients with additional surgery after ESD (ESD + OP group) and 252 patients without additional surgery (ESD-only group) were matched 1:1 using propensity scores to patients with surgery as initial treatment (surgery group). Overall survival (OS) and recurrence-free survival (RFS) were compared. RESULTS: Signet ring cell carcinoma and poorly differentiated adenocarcinoma (PDA) were observed in 939 and 1126 cases, respectively. OS was significantly longer in the surgery group than in the ESD + OP group, especially for PDA. However, RFS was shorter in the ESD-only group than those in the ESD + OP and surgery groups. RFS did not differ significantly between the ESD + OP and surgery groups. Compared to the surgery group, the ESD-only and ESD + OP groups had an overall hazard ratio for RFS of 3.58 (95% confidence interval 1.44-8.88) and 0.46 (0.10-2.20), respectively. CONCLUSIONS: ESD followed by additional surgery after non-curative resection showed comparable cancer-specific outcomes to initial surgery in UD EGC.

Association between proton pump inhibitor use and gastric cancer: a population-based cohort study using two different types of nationwide databases in Korea.

OBJECTIVE: The association between proton pump inhibitor (PPI) use and gastric cancer related to Helicobacter pylori eradication has not been fully investigated in geographical regions with high risk of gastric cancer. We aimed to evaluate the association between PPIs and gastric cancer in Korea. DESIGN: This study analysed the original and common data model versions of the Korean National Health Insurance Service database from 2002 to 2013. We compared the incidence rates of gastric cancer after 1-year drug exposure, between new users of PPIs and other drugs excluding PPIs, by Cox proportional hazards model. We also analysed the incidence of gastric cancer among PPI users after H. pylori eradication. RESULTS: The analysis included 11 741 patients in matched PPI and non-PPI cohorts after large-scale propensity score matching. During a median follow-up of 4.3 years, PPI use was associated with a 2.37-fold increased incidence of gastric cancer (PPI≥30 days vs non-PPI; 118/51 813 person-years vs 40/49 729 person-years; HR 2.37, 95% CI 1.56 to 3.68, p=0.001). The incidence rates of gastric cancer showed an increasing trend parallel to the duration of PPI use. In H. pylori-eradicated subjects, the incidence of gastric cancer was significantly associated with PPI use over 180 days compared with the non-PPI group (PPI≥180 days vs non-PPI; 30/12 470 person-years vs 9/7814 person-years; HR 2.22, 95% CI 1.05 to 4.67, p=0.036). CONCLUSION: PPI use was associated with gastric cancer, regardless of H. pylori eradication status. Long-term PPIs should be used with caution in high-risk regions for gastric cancer.

Clinical outcomes of endoscopic resection for undifferentiated intramucosal early gastric cancer larger than 2 cm.

BACKGROUND: This study investigated the long-term clinical outcomes of endoscopic resection (ER) for undifferentiated-type (UD) early gastric cancer (EGC), with tumor size > 2 cm as the only non-curative factor. METHODS: From among 1123 patients who underwent ER for UD EGC at 18 tertiary hospitals in Korea between 2005 and 2014, we identified 216 patients with UD intramucosal EGC > 2 cm, which was completely resected, with negative resection margins, and absence of ulceration and lymphovascular invasion. The patients were divided into the additional surgery (n = 40) or observation (n = 176) groups, according to post-ER management and were followed up for a median duration of 59 months for recurrence and 90 months for overall survival. RESULTS: Lymph node (LN) or distant metastasis or cancer-related mortality was not observed in the surgery group. In the observation group, two (1.1%) patients developed LN or distant metastasis with a 5-year cumulative risk of 0.7%, and one (0.6%) patient died of gastric cancer. The 5- and 8-year overall survival rates were 94.1% and 89.9%, respectively, in the observation group and 100.0% and 95.2%, respectively, in the surgery group (log-rank P = 0.159). Cox regression analysis did not reveal an association between the observation group and increased mortality. CONCLUSION: The risk of LN or distant metastasis was not negligible, but as low as 1% for patients undergoing non-curative ER for UD EGC, with tumor size > 2 cm as the only non-curative factor. Close observation may be an alternative to surgery, especially for older patients or those with poor physical status.

Comparison between endoscopic submucosal resection and surgery for the curative resection of undifferentiated-type early gastric cancer within expanded indications: a nationwide multi-center study.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) for undifferentiated early gastric cancer (UD EGC) has debate due to the risk of lymph node metastasis. We investigated the outcomes of ESD compared to those of surgery for the UD EGC within expanded indication. METHODS: We reviewed 971 UD EGC patients performed ESD across 18 hospitals in Korea and 1812 patients who underwent surgical resection in two hospitals between February 2005 and May 2015. Of these cases, we enrolled a curative resected ESD group of 328 patients and surgery group of 383 cases within an expanded indication. Overall outcomes and one-to-one propensity score-matched (218 ESD group vs 218 surgery group cases) outcomes for these two groups were analyzed. RESULTS: Over the 75.6 month median follow-up period for the 711 enrolled cases, recurrences occurred in 22 patients (6.7%) in the ESD group but not in the surgery group. Overall survival (OS) was higher in the surgery group (p = 0.0316) in all cases, but there was no significant difference after propensity score matching (p = 0.069). According to the histologic type in propensity score matching, the OS of signet ring cell carcinoma and poorly differentiated carcinoma patients did not differ between the ESD and surgery groups (p = 0.1189 and p = 0.3087, respectively). In the surgery group involving expanded criteria, lymph node metastasis was found in six cases (1.56%). CONCLUSIONS: Although ESD shows comparable outcomes to surgery for the UD EGC within expanded indications, appropriate patient selection is needed for the ESD due to the possibility of lymph node metastasis.

Risk factors of lymph node metastasis after non-curative endoscopic resection of undifferentiated-type early gastric cancer.

BACKGROUND: This study aimed to investigate risk factors for lymph node (LN) or distant metastasis after non-curative endoscopic resection (ER) of undifferentiated-type early gastric cancer (EGC). METHODS: Of 1124 patients who underwent ER for undifferentiated-type gastric cancer at 18 tertiary hospitals across six geographic areas in Korea between 2005 and 2014, 634 with non-curative ER beyond the expanded criteria were retrospectively enrolled. According to the treatment after ER, patients were divided into additional surgery (n = 270) and follow-up (n = 364) groups. The median follow-up duration was 59 months for recurrence and 84 months for mortality. RESULTS: LN metastasis was found in 6.7% (18/270) of patients at surgery. Ulcer [odds ratio (OR) 3.83; 95% confidence interval (CI) 1.21-12.13; p = 0.022] and submucosal invasion (OR 10.35; 95% CI 1.35-79.48; p = 0.025) were independent risk factors. In the follow-up group, seven patients (1.9%) developed LN or distant recurrence. Ulcer [hazard ratio (HR) 7.60; 95% CI 1.39-35.74; p = 0.018], LVI (HR 6.80; 95% CI 1.07-42.99; p = 0.042), and positive vertical margin (HR 6.71; 95% CI 1.28-35.19; p = 0.024) were independent risk factors. In the overall cohort, LN metastasis rates were 9.6% in patients with two or more risk factors and 1.2% in those with no or one risk factor. CONCLUSIONS: LVI, ulcer, submucosal invasion, and positive vertical margin are independently associated with LN or distant metastasis after non-curative ER of undifferentiated-type EGC. Surgical resection is strongly recommended for patients with two or more risk factors.

Establishing Machine Learning Models to Predict Curative Resection in Early Gastric Cancer with Undifferentiated Histology: Development and Usability Study.

BACKGROUND: Undifferentiated type of early gastric cancer (U-EGC) is included among the expanded indications of endoscopic submucosal dissection (ESD); however, the rate of curative resection remains unsatisfactory. Endoscopists predict the probability of curative resection by considering the size and shape of the lesion and whether ulcers are present or not. The location of the lesion, indicating the likely technical difficulty, is also considered. OBJECTIVE: The aim of this study was to establish machine learning (ML) models to better predict the possibility of curative resection in U-EGC prior to ESD. METHODS: A nationwide cohort of 2703 U-EGCs treated by ESD or surgery were adopted for the training and internal validation cohorts. Separately, an independent data set of the Korean ESD registry (n=275) and an Asan medical center data set (n=127) treated by ESD were chosen for external validation. Eighteen ML classifiers were selected to establish prediction models of curative resection with the following variables: age; sex; location, size, and shape of the lesion; and whether ulcers were present or not. RESULTS: Among the 18 models, the extreme gradient boosting classifier showed the best performance (internal validation accuracy 93.4%, 95% CI 90.4%-96.4%; precision 92.6%, 95% CI 89.5%-95.7%; recall 99.0%, 95% CI 97.8%-99.9%; and F1 score 95.7%, 95% CI 93.3%-98.1%). Attempts at external validation showed substantial accuracy (first external validation 81.5%, 95% CI 76.9%-86.1% and second external validation 89.8%, 95% CI 84.5%-95.1%). Lesion size was the most important feature in each explainable artificial intelligence analysis. CONCLUSIONS: We established an ML model capable of accurately predicting the curative resection of U-EGC before ESD by considering the morphological and ecological characteristics of the lesions.

Impact of the timing of Helicobacter pylori eradication on the risk of development of metachronous lesions after treatment of early gastric cancer: a population-based cohort study.

BACKGROUND AND AIMS: Helicobacter pylori eradication can reduce the risk of metachronous lesions after the treatment of early gastric cancer. We aimed to analyze the impact of the timing of H pylori eradication on metachronous recurrence. METHODS: Data of patients who underwent endoscopic resection or partial gastrectomy for early stage gastric cancer and received H pylori eradication therapy were obtained from the Korean National Health Insurance Service database. Patients were classified into 3 groups according to the timing of the prescription for H pylori eradication: preresection; within 1 year postresection; and >1 year postresection. RESULTS: Among 19,767 patients, 7452 and 12,315 underwent endoscopic resection and surgery, respectively. The 5-year cumulative incidence of metachronous lesions after endoscopic resection was 14.0% in the preresection group, 12.3% in the within 1 year postresection group, and 16.9% in the >1 year postresection group. Surgery was performed in 1.2% of the preresection group, 1.3% of the within 1 year postresection group, and 2.9% of the >1 year postresection group. The within 1 year postresection group had a lower risk of development of metachronous lesions than the >1 year postresection group (hazard ratio [95% confidence interval]: after endoscopic resection, 0.79 [0.65-0.95]; after surgery, 0.39 [0.28-0.53]). The risk of development of metachronous lesions did not differ between the preresection and within 1 year postresection groups. CONCLUSION: Prescription of H pylori eradication therapy within 1 year after gastric cancer treatment reduces the risk of development of metachronous gastric neoplasms compared with a late prescription of eradication therapy in patients undergoing endoscopic resection and those undergoing surgery.

Comparative risk of Clostridium difficile infection between proton pump inhibitors and histamine-2 receptor antagonists: A 15-year hospital cohort study using a common data model.

BACKGROUNDS AND AIM: There are potential concerns regarding infectious complications including Clostridium difficile infections (CDIs) among patients taking gastric acid suppressants. Furthermore, it is speculated that the stronger acid suppression by proton pump inhibitors (PPIs) potentially enhance infectious complications. This study aimed to compare the risk of CDI between PPIs and histamine-2 receptor antagonists (H2RAs). METHODS: Using the long-term database of the Kangdong Sacred Heart Hospital, converted to the Observational Medical Outcomes Partnership Common Data Model, we identified outpatients treated with PPIs and H2RAs for ≥ 7 days from January 1, 2004 through December 31, 2018. We conducted Cox regression analysis to examine the hazard ratio (HR) of CDI after propensity score matching. RESULTS: During a median follow-up period of 1.2 years (interquartile range, 0.2-3.2 years), the initial CDI occurrence differed significantly between matched cohorts of patients taking PPIs and H2RAs [PPIs vs H2RAs, 88/31 095 person years vs 47/32 836 person years; HR, 2.22; 95% confidence interval (CI) 1.29-3.96; P = 0.005]. Almost 50% of all events occurred within 1 year of drug exposure. The risk of CDIs was significantly greater among groups receiving PPIs or H2RAs than in matched controls (PPIs vs control: HR, 2.65; 95% CI 1.28-5.79; P = 0.011; and H2RAs vs control: HR 2.43; 95% CI 1.09-5.68; P = 0.034]. CONCLUSION: In long-term hospital cohort, outpatient-based PPIs were associated with greater risk of CDI than H2RAs. It is necessary to be cautioned about complication of CDI in patients taking long-term PPI therapy.

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.

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.

Effect of gastroprotective agents on upper gastrointestinal bleeding in patients receiving direct oral anticoagulants.

OBJECTIVES: Direct oral anticoagulants (DOACs) are effective in the prevention and treatment of thromboembolism; however, they are associated with upper gastrointestinal bleeding (UGIB). In this study, we evaluated the efficacy of gastroprotective agents (GPAs) in reducing the risk of UGIB in patients receiving DOACs. METHODS: We retrospectively reviewed the medical records of 2076 patients who received DOACs for the prevention or treatment of thromboembolic events between January 2008 and July 2016. A cumulative incidence analysis using the Kaplan-Meier method was performed to determine the rate of UGIB and its association with GPAs administration. RESULTS: Of the 2076 patients, 360 received GPAs. Over the follow-up period (1160 person-years), one patient in the GPA group (0.7 per 100 person-years) and 29 patients in the non-GPA group (2.8 per 100 person-years) developed UGIB (p = .189). In the multivariate analysis, UGIB was associated with older age (hazard ratio (HR), 1.041; p = .048), a history of peptic ulcer or UGIB (HR, 5.931; p < .001), and concomitant use of antiplatelet agents (HR, 3.121; p = .014). GPAs administration did not reduce the risk of UGIB (p = .289). However, based on the subgroup analysis of 225 patients with concomitant use of antiplatelet agents or a history of peptic ulcer or UGIB, the GPA group (0 per 100 person-years) showed reduced incidence of UGIB compared with the non-GPA group (11.3 per 100 person-years) (p = .065). CONCLUSIONS: The prophylactic use of GPAs could reduce the risk of UGIB in patients receiving DOACs who have risk factors, such as concomitant use of antiplatelet agents or a history of peptic ulcer or UGIB.

Efficacy and tolerability of 2-L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate: a randomized controlled trial.

BACKGROUND/AIM: Previous studies comparing 2-L polyethylene glycol (PEG)-based solution with ascorbic acid (PEG/Asc) with sodium picosulfate/magnesium citrate (SP/MC) drew inconclusive results. This study aimed to compare a 2-L-PEG/Asc with SP/MC by split method in bowel cleansing efficacy, tolerability, and safety and to identify factors influencing inadequate bowel preparation. METHOD: We performed a prospective randomized, endoscopist-blinded, single-center, controlled trial. The Aronchick scale and Ottawa bowel preparation scale (OBPS) were used to evaluate the bowel cleansing efficacy, and patients' tolerability and preferences were assessed by questionnaire. RESULTS: In total, 223 patients were randomized to receive 2-L-PEG/Asc (n = 109) or SP/MC (n = 114). There was no significant difference in overall bowel cleansing efficacy between the two groups; however, when analyzing by individual segment, mean bowel cleansing efficacy of right colon showed a trend in favor of SP/MC group than in PEG/Asc group (OBPS; 1.55 ± 0.66 vs. 1.74 ± 0.88, P = 0.08). Furthermore, SP/MC was better tolerated than PEG/Asc based on ease of consumption and preference to receive the agents again in the future. Total adverse events were significantly lower in SP/MC group than PEG/Asc group (47.4 vs. 62.4%, P = 0.031). In multivariate analysis, later colonoscopic starting time was the only independent factor predicting inadequate bowel preparation (OR 1.39, 95% CI 1.156-1.692, P = 0.001). CONCLUSIONS: There was no significant difference in overall bowel cleansing efficacy between PEG/Asc and SP/MC; however, SP/MC showed better tolerability and safety profile than PEG/Asc. The independent factor for inadequate bowel preparation was later colonoscopic starting time when applied split method.

Eradication Rates of Helicobacter pylori in Korea Over the Past 10 years and Correlation of the Amount of Antibiotics Use: Nationwide Survey.

BACKGROUND: The efficacy of proton-pump inhibitor-amoxicillin-clarithromycin therapy for H. pylori eradication has decreased over time. OBJECTIVE: We assessed the trend of H. pylori eradication rates over the last 10 years and the relationship between the eradication rates and the amount of macrolide antibiotic use in a country with a high prevalence of H. pylori infection. METHODS: This vast nationwide multicenter study was conducted with 34,139 adults treated for H. pylori infection from January 2001 to December 2010. The defined daily dose per km(2) (DSD) of macrolide antibiotics was calculated (n = 141,019) using the Health Insurance Review & Assessment data base from 2008 to 2010 in the two cities which had the lowest (Jeju city) or highest (Chuncheon city) eradication rate. RESULTS: The eradication rates of proton-pump inhibitor-amoxicillin-clarithromycin therapy ranged 84.9-87.5% from 2001 to 2007, and those of 2008 to 2010 ranged 80.0-81.4% with a decreasing trend (p < 0.0001). The decreasing trend of eradication rates for the overall first-line therapy was observed only in three of the seven geographic areas in Korea (p < 0.0001). The DSD of macrolide antibiotics was significantly higher in Jeju than Cheunchon city (0.85 vs 0.52, p < 0.0001). CONCLUSIONS: H. pylori eradication rates with clarithromycin-containing triple therapy in Korea showed a decreasing trend over the past 10 years, although the trend varied among geographic areas. This difference may be associated with the amount of macrolide antibiotic use.

Safety of Target-Controlled Propofol Infusion by Gastroenterologists in Patients Undergoing Endoscopic Resection.

BACKGROUND: A target-controlled infusion (TCI) of a propofol system uses a pharmacokinetic model to achieve and maintain a selected target blood propofol concentration. The aim of this study was to assess whether the propofol TCI system could be safely used by gastroenterologists in patients undergoing endoscopic resection including endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) compared with a manually controlled infusion (MCI) system. METHODS: A total of 431 patients undergoing therapeutic endoscopy (178 ESD and 253 EMR) were consecutively included from November 2011 to August 2014. The patients were divided into the MCI (271) and TCI (160) propofol infusion groups. We compared adverse event rates in MCI and TCI groups and assessed independent risk factors for adverse events. RESULTS: The total sedation-related adverse event rate was 5.8 % (25/431). Most of the events were minor, and the rate of major events was 0.5 % (2/431). There was no significant difference in adverse event rate between the MCI and TCI groups [5.5 % (15/271) vs. 6.3 % (10/160); P = 0.759]. In univariate analysis, the propofol infusion time was significantly associated with adverse events (94.88 vs. 59.45 min, P = 0.017). In the multivariate analysis, there were no significant factors associated with adverse events. TCI was not an independent risk factor for adverse events despite the fact that the TCI had a longer duration of infusion and higher total infusion dose (95 % CI, 0.343-2.216; P = 0.773). CONCLUSIONS: TCI of propofol by gastroenterologists may provide safe sedation in patients undergoing ESD and EMR under careful respiratory monitoring.

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis.

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

Is There Any Difference in the Eradication Rate of Helicobacter pylori Infection According to the Endoscopic Stage of Peptic Ulcer Disease?

BACKGROUND: The eradication rate of Helicobacter pylori (H. pylori) infection might be affected by the degree of inflammation of gastric mucosa represented by the endoscopic stage of peptic ulcer disease (PUD). The aims of this study were to evaluate the eradication rates of H. pylori infection according to the endoscopic stage of PUD and to document whether early eradication in the active stage could yield a higher eradication rate in patients with peptic ulcer bleeding (PUB). MATERIALS AND METHODS: A total of 1,177 patients with PUD (380 gastric ulcer, 710 duodenal ulcer, and 87 combined ulcer) who received proton-pump inhibitor (PPI)-based triple therapy were included, and the eradication rates were compared by ulcer stage. Univariate and multivariate analyses were conducted to identify factors influencing eradication rate. In PUB, the eradication rates between the early eradication group (≤7 days) and the late eradication group (>7 days) were compared. RESULTS: The eradication rates according to endoscopic stage were significantly different in gastric ulcer (active vs healing vs scarring; 84.8% vs 82.7% vs 70.6%, p = .014, respectively), but there were no significant differences in duodenal ulcer (active vs healing vs scarring; 87.6% vs 80.9%% vs 80.9% p = .169, respectively). In multivariate analyses, active ulcer as well as age younger than 50 was a significantly independent predictor of successful eradication (Odds ratio; 2.799, 95% CI; 1.659-4.723, p = .0001). The eradication rate of the early eradication group was significantly higher than the late eradication group in PUB (89.2% vs 71.9%, 95% CI; 1.265-8.269, p = .011). CONCLUSIONS: There was a significant difference in the eradication rate according to the endoscopic stage of gastric ulcer. Active ulcer was an independent predictor of successful eradication. Furthermore, early H. pylori eradication should be considered in patients with PUB to yield a higher eradication rate.