Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study.

Background/Aims: H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis. Methods: A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared. Results: According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different. Conclusions: DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).

Significance of 8-OHdG Expression as a Predictor of Survival in Colorectal Cancer.

The incidence of colorectal cancer (CRC) is increasing worldwide. 8-hydroxy-2'-deoxyguanosine (8-OHdG), one of the most prevalent DNA alterations, is known to be upregulated in several carcinomas; however, 8-OHdG has not been used to predict the prognosis of patients with CRC. We aimed to determine 8-OHdG levels in patients with CRC using immunohistochemistry and conducted a survival analysis according to the pathological stage. The 5-year event-free survival (EFS) and disease-specific survival (DSS) hazard ratios (HRs) of the low 8-OHdG subgroup were 1.41 (95% confidence interval (CI): 1.01-1.98, p = 0.04) and 1.60 (95% CI: 1.12-2.28, p = 0.01), respectively. When tumor node metastasis (TNM) staging and 8-OHdG expression were combined, the 5-year EFS and DSS HRs of patients with CRC with low 8-OHdG expression cancer at the same TNM stage (stage Ⅲ/Ⅳ) were 1.51 (95% CI: 1.02-2.22, p = 0.04) and 1.64 (95% CI: 1.09-2.48, p = 0.02), respectively, compared to those with high 8-OHdG expression cancer, indicating a poor prognosis. Therefore, low 8-OHdG expression is a significant predictive factor for 5-year EFS and DSS in patients with CRC, and it can serve as an essential biomarker of CRC.

Efficacy and safety of intragastric balloon for obesity in Korea.

BACKGROUND/AIMS: Intragastric balloon (IGB) is the only available endoscopic bariatric and metabolic therapy in Korea. End-ball (Endalis) has the longest history of clinical use among the IGBs available in Korea. However, little clinical data on this system have been reported. In this study, we aimed to evaluate the efficacy and safety of End-ball in Korea. METHODS: We performed a retrospective cohort study of patients who underwent IGB insertion (End-ball) from 2013 to 2019. Demographic and anthropometric data were collected. The efficacy and safety of IGB treatment were analyzed. RESULTS: In total, 80 patients were included. Mean age was 33.7 years and 83.8% were female. Initial body mass index was 34.48±4.69 kg/m2. Body mass index reduction was 3.72±2.63 kg/m2 at the time of IGB removal. Percent of total body weight loss (%TBWL) was 10.76%±6.76%. Percentage excess body weight loss was 43.67%±27.59%. Most adverse events were minor, and 71.4% of participants showed nausea, vomiting, or abdominal pain. CONCLUSION: IGB treatment showed good efficacy and safety profile in Korean patients with obesity. In terms of %TBWL and percentage excess body weight loss, the efficacy was similar to that in the Western population.

Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial.

Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)- based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions: TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea (ClinicalTrials.gov identifier NCT03317223).

Therapeutic Potential of Sitafloxacin as a New Drug Candidate for Helicobacter Eradication in Korea: An In Vitro Culture-Based Study.

BACKGROUND: Increased prevalence of antibiotic resistance to Helicobacter pylori (H. pylori) infection worldwide has driven the search for a new therapeutic candidate. Recently, sitafloxacin, a novel 4-quinolone agent, has emerged as a new therapeutic option for H. pylori eradication, in Japan. However, data on its efficacy for H. pylori eradication in Korea are limited. Therefore, we aimed to investigate the therapeutic potential of sitafloxacin as a first-line treatment for patients with Helicobacter infection through gastric tissue culture-based studies. MATERIALS AND METHODS: We prospectively enrolled treatment-naïve patients with H. pylori infection who visited the Gil Medical Center between March 2015 and March 2018. After obtaining written informed consent from patients, a total of 121 H. pylori strains were collected. We tested the susceptibility of these strains to sitafloxacin, and other antibiotics for Helicobacter eradication, including clarithromycin (CLR), metronidazole (MTZ), amoxicillin (AMX), tetracycline (TET), levofloxacin (LEV), and ciprofloxacin (CIP) using the agar dilution technique. The minimum inhibitory concentration (MIC) of these antibiotics against H. pylori strains were determined. RESULTS: None of the H. pylori strains obtained were resistant to sitafloxacin (MIC > 1, n = 0), while other conventional eradication drugs including CLR, MTZ, AMX, and TET showed 24.8% (n = 30), 30.6% (n = 37), 5.0% (n = 6), and 0.8% (n = 1) resistance, respectively. Compared to the resistance rates of other quinolones (LEV [36.4%, n = 44] and CIP [37.2%, n = 45]), sitafloxacin showed the best antibiotic performance against Helicobacter strains (0%, n = 0). Furthermore, sitafloxacin also inhibited the growth of 14 H. pylori strains (12.4%), which were resistant to both of clarithromycin, and metronidazole, and 27 strains (22.3%) with multidrug resistance. CONCLUSIONS: Sitafloxacin might be a new promising candidate for Helicobacter eradication where antibiotic resistance for Helicobacter is an emerging medical burden, such as in Korea.

Tailored eradication strategy vs concomitant therapy for Helicobacter pylori eradication treatment in Korean patients.

BACKGROUND: Antibiotic resistance to Helicobacter pylori (H. pylori) infection, which ultimately results in eradication failure, has been an emerging issue in the clinical field. Recently, to overcome this problem, an antibiotic sensitivity-based tailored therapy (TT) for H. pylori infection has received attention. AIM: To investigate the efficacy and safety profiles of TT for H. pylori infection treatment compared to a non-bismuth quadruple therapy, concomitant therapy (CT) regimen. METHODS: We included patients (> 18 years) with an H. pylori infection and without a history of Helicobacter eradication who visited the Gil Medical Center between March 2016 and October 2020. After being randomly assigned to either the TT or CT treatment group in 1 to 1 manner, patient compliance, eradication success rate (ESR), and patient-reported side effects profiles were assessed and compared between the two groups. H. pylori infection was diagnosed using a rapid urease test, Giemsa stain, or dual priming oligonucleotide polymerase chain reaction (DPO-PCR). Tailored eradication strategy based through the presence of a 23S ribosomal RNA point mutation. For the TT group, a DPO-PCR test, which detected A2142G and/or A2143G point mutations, and a clarithromycin resistance test were performed. Patients in the clarithromycin-resistant group were treated with a bismuth-containing quadruple combination therapy, while those with sensitive results were treated with the standard triple regimen. RESULTS: Of the 217 patients with a treatment naive H. pylori infection, 110 patients [mean age: 58.66 ± 13.03, men, n = 55 (50%)] were treated with TT, and 107 patients [mean age: 56.67 ± 10.88, men, n = 52 (48.60%)] were treated with CT. The compliance (TT vs CT, 100% vs 98.13%, P = 0.30), and follow-up loss rates (8.18% vs 9.35%, P = 0.95) were not significantly different between the groups. The ESR after treatment was also not statistically different between the groups (TT vs CT, 82.73% vs 82.24%, P = 0.95). However, the treatment-related and patient-reported side effects were significantly lower in the TT group than in the CT group (22.77% vs 50.52%, P < 0.001). CONCLUSION: The DPO-based TT regimen shows promising results in efficacy and safety profiles as a first-line Helicobacter eradication regimen in Korea, especially when physicians are confronted with increased antibiotic resistance rates.

Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study.

Background/Aims: : The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of MucostaⓇ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or MucostaⓇ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; MucostaⓇ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; MucostaⓇ, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was -4.01% (95% confidence interval [CI], -13.09% to 5.06%) in the ITT analysis and -4.44% (95% CI, -13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 MucostaⓇ-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (MucostaⓇ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Dedicated Cold Snare vs. Traditional Snare for Polypectomy of Diminutive and Small Lesions in a Porcine Model: A Research Group for Endoscopic Instruments and Stents (REIS) Study.

BACKGROUND/AIMS: The aim of this in vivo animal study was to evaluate the effectiveness and safety of dedicated cold snare (DCS) compared with those of traditional snare (TS) for cold snare polypectomy (CSP). METHODS: A total of 36 diminutive (5 mm) and 36 small (9 mm) pseudolesions were made by electrocoagulation in the colons of mini-pigs. RESULTS: For the diminutive lesions, there were no significant differences in technical success rate, procedure time, or complete resection rate between the DCS and TS groups; the rate of uneven resection margin in the DCS group was significantly lower than that of the TS group. For small lesions, technical success rate and complete resection rate were significantly higher in the DCS group than in the TS group (100% [18/18] vs. 55.6% [10/18], p=0.003; 94.4% [17/18] vs. 40% [4/10], p=0.006). In addition, the procedure duration was significantly shorter, and the rate of uneven resection margin was significantly lower in the DCS group (28.5 sec vs. 66.0 sec, p=0.006; 11.1% [2/18] vs. 100% [10/10], p<0.001). Two cases of perforation occurred in the DCS group. Multivariate analysis revealed that DCS use was independently associated with complete resection. CONCLUSION: DCS is superior to TS in terms of technical success, complete resection, and reducing the duration of the procedure for CSP of small polyps.

Effects of Automatic Abdominal Massage Device in Treatment of Chronic Constipation Patients: A Prospective Study.

BACKGROUND AND AIM: Manual abdominal massage has been shown to effectively treat slow-transit constipation, but it is labor-intensive. To offer an alternative treatment option for constipation, the Bamk-001 automatic abdominal massage device was developed. The aim of this study was to assess the effect of the Bamk-001 device on symptom profiles and colon transit time (CTT) in patients with chronic constipation. METHODS: Thirty-seven patients with chronic functional constipation diagnosed using the Rome IV criteria were enrolled prospectively from December 2018 to February 2019. All patients received device-assisted automatic abdominal massage for 15 min twice daily, once in the morning before breakfast and once at night, for 14 days. CTT was measured before and at the end of the study period. Slow-transit constipation and very-slow-transit constipation were defined as CTT ≥ 48 h and ≥ 72 h, respectively. Patients' symptom profiles regarding overall defecation satisfaction and device-related adverse events were analyzed. RESULTS: Among the 37 patients, the mean age was 40.1 ± 11.8, and 5.4% (n = 2) were men. The Bamk-001 device significantly improved CTT from 54.0 (33.6-75.6) to 28.8 (18.0-52.8) h (p = 0.001) in patients with chronic constipation. In subgroup analysis, CTT improved significantly from 54.0 (33.6-75.6) to 28.8 (18.0-52.8) h (p = 0.003) and from 88.2 (74.4-124.8) to 45.6 (27.3-74.1) h (p = 0.005) in the slow-transit and very-slow-transit constipation groups, respectively (p = 0.001). Moreover, all patient symptoms were alleviated after treatment. No serious adverse events were reported. CONCLUSION: The Bamk-001 automatic abdominal massage device showed significant care efficacy, including the improvement in CTT and symptom profiles in patients with slow-transit constipation. The use of an automatic abdominal massage device as an adjunct in the management of constipation is a potentially beneficial intervention for patients with slow-transit constipation.

Development of Machine Learning Model to Predict the 5-Year Risk of Starting Biologic Agents in Patients with Inflammatory Bowel Disease (IBD): K-CDM Network Study.

BACKGROUND: The incidence and global burden of inflammatory bowel disease (IBD) have steadily increased in the past few decades. Improved methods to stratify risk and predict disease-related outcomes are required for IBD. AIM: The aim of this study was to develop and validate a machine learning (ML) model to predict the 5-year risk of starting biologic agents in IBD patients. METHOD: We applied an ML method to the database of the Korean common data model (K-CDM) network, a data sharing consortium of tertiary centers in Korea, to develop a model to predict the 5-year risk of starting biologic agents in IBD patients. The records analyzed were those of patients diagnosed with IBD between January 2006 and June 2017 at Gil Medical Center (GMC; n = 1299) or present in the K-CDM network (n = 3286). The ML algorithm was developed to predict 5- year risk of starting biologic agents in IBD patients using data from GMC and externally validated with the K-CDM network database. RESULT: The ML model for prediction of IBD-related outcomes at 5 years after diagnosis yielded an area under the curve (AUC) of 0.86 (95% CI: 0.82-0.92), in an internal validation study carried out at GMC. The model performed consistently across a range of other datasets, including that of the K-CDM network (AUC = 0.81; 95% CI: 0.80-0.85), in an external validation study. CONCLUSION: The ML-based prediction model can be used to identify IBD-related outcomes in patients at risk, enabling physicians to perform close follow-up based on the patient's risk level, estimated through the ML algorithm.

Efficacy of iron supplementation in patients with inflammatory bowel disease treated with anti-tumor necrosis factor-alpha agents.

BACKGROUND: Anemia is a common extraintestinal manifestation of inflammatory bowel disease (IBD). However, data on the influence of anti-tumor necrosis factor-alpha (anti-TNF-α) agents and iron supplementation on anemia in patients with IBD are sparse. We assessed the effect of iron supplementation in patients with IBD initially treated with an anti-TNF-α agent. METHODS: Data from 79 IBD patients who started anti-TNF-α treatment at a tertiary hospital were analyzed. The patients were divided into the anti-TNF-α (n = 52) and anti-TNF-α with iron supplementation (n = 27) groups. Effects on laboratory parameters, the prevalence of anemia, and disease activity were evaluated at baseline (year 0) and 1 year later. RESULTS: The hemoglobin (Hb) level significantly increased between years 0 and 1 in both groups [12.0 ± 1.8-13.3 ± 2.0 g/dL in the anti-TNF-α group (p < 0.001) and 9.8 ± 2.4-11.7 ± 2.3 g/dL in the anti-TNF-α and iron supplementation group (p = 0.004)]. In a subgroup analysis of severely anemic patients with IBD, iron supplementation increased the magnitude of the improvement in Hb level (8.5 ± 1.5-11.4 ± 2.1 g/dL; p = 0.001) compared with the anti-TNF-α group (9.3 ± 0.8-11.4 ± 2.7 g/dL; p = 0.081). Disease activity was significantly improved in both groups at year 1 compared with year 0. Persistent anemia was significantly correlated with severe anemia at baseline (p = 0.017). CONCLUSION: In anemic patients with IBD, anti-TNF-α agents led to clinically meaningful improvements in anemia independent of iron supplementation. Also, iron supplementation could be helpful in severely anemic patients with IBD.

Efficacy and Patient Tolerability Profiles of Probiotic Solution with Bisacodyl Versus Conventional Cleansing Solution for Bowel Preparation: A Prospective, Randomized, Controlled Trial.

Although adequate bowel preparation is essential in screening colonoscopy, patient intolerability to bowel cleansing agents is problematic. Recently, a probiotic mixture solution with bisacodyl emerged to improve patient tolerability. We investigated the efficacy, safety, and patient tolerability profiles of probiotics with bisacodyl versus conventional polyethylene glycol (PEG) solution for bowel preparation for screening colonoscopies in healthy patients in this prospective, randomized, case-control study. In total, 385 volunteers were randomly assigned to receive 2 L of water + 200 mL of probiotic solution (case group, n = 195) or 4 L of PEG solution (control group, n = 190). The efficacy of the bowel cleansing was evaluated using the Ottawa scale system, polyp detection rate, and adenoma detection rate, and the patient tolerability profiles were assessed using a questionnaire. The demographics were not significantly different between groups. When the Ottawa score for each bowel segment was stratified into an adequate vs. inadequate level (Ottawa score ≤ 3 vs. >3), there were no statistical differences between groups in each segment of the colon. There were no significant differences in the polyp and adenoma detection rates between groups (38.42% vs. 32.42, p = 0.30; 25.79% vs. 18.97%, p = 0.11). The case group showed significantly fewer events than the control group, especially nausea, vomiting, and abdominal bloating events. Regarding the overall satisfaction grade, the case group reported significantly more "average" scores (95% vs. 44%, p < 0.001) and were more willing to use the same agents again (90.26% vs. 61.85%, p < 0.001). As patient compliance with bowel preparation agents is associated with an adequate level of bowel cleansing, a probiotic solution with bisacodyl might be a new bowel preparation candidate, especially in patients who show a poor compliance with conventional bowel preparation agents.

The Efficacy, Safety, and Convenience of a New Device for Flushing Intravenous Catheters (Baro Flush™): A Prospective Study.

Background and Objectives: An effective flushing technique is essential to reduce intravenous (IV)-related complications and improve patient care. New technology should contribute to such improvements, while reducing costs and increasing care efficiency. This study evaluated the efficacy, safety, and convenience of a new flushing technique using a Baro Flush™ controller. Materials and Methods: We evaluated the efficacy and safety of Baro Flush™ by measuring the infusion flushing volume and pressure in vitro. Afterwards, we prospectively enrolled 3000 patients with flushing and assigned 1500 patients with a new technique for flushing and 1500 with a conventional flushing method, which was performed by 48 registered nurses (RNs) at the Gil Medical Center in June 2018. The efficacy, safety, and convenience of the new flushing method were evaluated though a questionnaire survey. Results: The average flushing pressure was 12.5 ± 0.6 psi (86.18 ± 4.14 kPa) with 1.2 ± 0.2 mL per flush, as recommended by the Centers for Disease Control and Prevention based on 85 experiments. No IV-catheter-related complications were reported by the RNs during the study. More than 80% of the RNs reported that the new flushing method was easier to learn, improved care efficacy, and was more convenient than conventional flushing. Conclusions: The new flushing method using a Baro Flush™ controller showed improved efficacy, safety, and convenience compared with the conventional flushing method, and no IV-catheter-related complications occurred, including occlusion and inflammation. The new flushing method promises to reduce IV-catheter-related complications and shows improved efficacy, safety, and convenience.

Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer.

BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders. AIMS: To assess whether tegoprazan is non-inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers. METHODS: In this phase 3, double-blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed. RESULTS: In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4-week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug-related treatment-emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan-treated patients than in lansoprazole-treated patients. CONCLUSIONS: Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers.

Effect of work-related factors on the prevalence of peptic ulcer disease among Korean workers: a nationwide population-based study.

BACKGROUND: Working environment such as psychosocial factors impacts the health of workers. However, few studies have assessed the association of work-related factors with the prevalence of peptic ulcer disease (PUD) in large population based study. METHODS: After exclusion of military personnel, 16,099 wage workers (20 ≤ age ≤ 65 years) from the Fourth Korea National Health and Nutrition Examination Survey (2008-2011) were included in this study. Job status was defined as the place of employment of longest duration. To evaluate the working environment, we used a comprehensive work-stressor measure. Univariate and multivariable regression analyses were performed to assess the effect of occupation type on the prevalence of PUD. RESULTS: Among the subjects, 5540, 3398, and 7161 were white-, pink-, and blue-collar workers, respectively. The prevalence of PUD was highest among blue-collar workers (n = 336, 7.1%), followed by pink-collar (n = 116, 5.1%) and white-collar (n = 180, 4.9%) workers. In the multivariable analysis, work type and uncomfortable gestures were independently associated with the risk of PUD. Compared with office workers, operators in industrial plants and machine operators had a significantly higher prevalence of PUD (odds ratio, 1.9; 95% confidence interval, 1.1-3.3) after adjusting for age, socioeconomic factors, sex, smoking, alcohol consumption, daily exercise, sleep duration, and working conditions. DISCUSSION: In conclusion, work-related factors, particularly blue-collar work and uncomfortable job gestures, are independently associated with the risk of PUD. Therefore, it is important to monitor the development of PUD in workers exposed to these factors.

Stenting as a bridge to surgery for extra-colonic malignancy induced colorectal obstruction: preliminary experience.

BACKGROUND: The majority of colonic obstructions result from colorectal cancer. However, malignancies of extra-colonic origin can also disrupt colorectal patency, and the efficacy of self-expanding metal stents (SEMS) insertion as a bridge to surgery in these patients are still in debate. The aim of this study is to evaluate the efficacy of endoscopic stenting as a bridge to surgery (BTS) for extra-colonic malignancy (ECM)-induced colonic obstruction. METHODS: Thirty-three patients with colonic obstruction due to ECM who received self-expanding metal stents (SEMS) insertion at a single academic tertiary medical center between 2004 and 2015 were included. The purpose of SEMS insertion was determined based on whether the patient's medical records indicated any surgical plans before SEMS insertion. Technical success was defined as a patent SEMS covering the entire length of the obstruction. Bridging success was defined as elective surgical procedures after the first SEMS insertion. RESULTS: Among the 33 patients who underwent SEMS insertion for colorectal obstruction due to ECM, nine underwent SEMS as a BTS. Technical success was achieved in 100% (9/9). Seven patients underwent elective surgery after successful decompression with the first SEMS, and the bridging success rate was 77.8% (7/9). Two patients needed secondary stent insertion before elective surgery. However, none of them required emergent surgery. No major complications occurred, including death related to colorectal endoscopic procedures, perforation, or bleeding. CONCLUSION: SEMS insertion as a BTS is a good treatment option to avoid emergent surgery in patients with colonic obstruction caused by extra-colonic malignancy.

Effect of Age on the Initiation of Biologic Agent Therapy in Patients With Inflammatory Bowel Disease: Korean Common Data Model Cohort Study.

BACKGROUND: The Observational Health Data Sciences and Informatics (OHDSI) network is an international collaboration established to apply open-source data analytics to a large network of health databases, including the Korean common data model (K-CDM) network. OBJECTIVE: The aim of this study is to analyze the effect that age at diagnosis has on the prognosis of inflammatory bowel disease (IBD) in Korea using a CDM network database. METHODS: We retrospectively analyzed the K-CDM network database from 2005 to 2015. We transformed the electronic medical record into the CDM version 5.0 used in OHDSI. A worsened IBD prognosis was defined as the initiation of therapy with biologic agents, including infliximab and adalimumab. To evaluate the effect that age at diagnosis had on the prognosis of IBD, we divided the patients into an early-onset (EO) IBD group (age at diagnosis <40 years) and a late-onset (LO) IBD group (age at diagnosis ≥40 years) with the cutoff value of age at diagnosis as 40 years, which was calculated using the Youden index method. We then used the logrank test and Cox proportional hazards model to analyze the effect that age at diagnosis (EO group vs LO group) had on the prognosis in patients with IBD. RESULTS: A total of 3480 patients were enrolled. There was 2017 patients with ulcerative colitis (UC) and 1463 with Crohn's disease (CD). The median follow up period was 109.5 weeks. The EO UC group was statistically significant and showed less event-free survival (ie, experiences of biologic agents) than the LO UC group (P<.001). In CD, the EO CD group showed less event-free survival (ie, experiences of biologic agents) than the LO CD group. In the Cox proportional hazard analysis, the odds ratio (OR) of the EO UC group on experiences of biologic agents compared with the LO UC group was 2.3 (95% CI 1.3-3.8, P=.002). The OR of the EO CD group on experiences of biologic agents compared with the LO CD group was 5.4 (95% CI 1.9-14.9, P=.001). CONCLUSIONS: The EO IBD group showed a worse prognosis than the LO IBD group in Korean patients with IBD. In addition, this study successfully verified the CDM model in gastrointestinal research.

Comparative efficacy of bariatric endoscopic procedures in the treatment of morbid obesity: a systematic review and network meta-analysis.

BACKGROUND: The comparative efficacy of bariatric endoscopic procedures has not been completely elucidated. We aimed to comprehensively evaluate the efficacy of bariatric endoscopic procedures. METHODS: We searched for randomized controlled trials investigating the efficacy of bariatric endoscopic procedures, including the use of an intragastric balloon, duodenal-jejunal bypass liner (DJBL), aspiration therapy, primary obesity surgery endoluminal (POSE) procedure, and botulinum toxin injection to the stomach. Network meta-analyses were performed to determine the percentage of weight loss (%weight loss) and percentage of excess weight loss (%EWL). RESULTS: 22 studies with 2141 patients were included in the meta-analysis. Most endoscopic procedures showed superior efficacy in terms of %weight loss compared with the control (mean difference [MD] [95 % confidence interval (CI)]: aspiration therapy 10.4 % [7.0 % to 13.7 %]; fluid-filled balloon 5.3 % [3.4 % to 7.2 %]; POSE 4.9 % [1.7 % to 8.2 %]; and DJBL 4.5 % [1.4 % to 7.7 %]). In terms of %EWL, aspiration therapy, fluid-filled balloon, POSE, and DJBL were superior to the control (MD [95 %CI]: 27.3 % [15.3 % to 39.3 %]; 22.4 % [15.4 % to 29.4 %]; 15.3 % [2.5 % to 28.0 %]; and 13.0 % [4.9 % to 21.2], respectively). The gas-filled balloon and botulinum toxin injection did not show a significant difference in %weight loss or %EWL compared with the control. For the fluid-filled balloon, the %EWL and %weight loss tended to decrease after balloon removal at 6 months after the procedure. CONCLUSION: All bariatric endoscopic procedures, except for gas-filled balloon and botulinum toxin injection to the stomach, showed superior short-term efficacy in terms of %weight loss or %EWL compared with lifestyle modification.

Efficacy of repeat forward-view examination of the right-sided colon during colonoscopy: A prospective randomized controlled trial.

BACKGROUND AND AIM: Generally, colonoscopy is less effective for detecting colorectal adenomas in the right-sided colon compared with the distal colon. Repeat forward-view (RF) examination of the right-sided colon has been suggested to increase the adenoma detection rate (ADR). However, studies investigating the efficacy of RF examination are lacking. Thus, the aim of this study was to determine whether RF examination in the right-sided colon enhances right-sided ADR. METHODS: We performed a prospective, randomized controlled trial, including asymptomatic subjects who underwent screening colonoscopy. Subjects were randomized to the RF group, in which the right-sided colon was examined twice in the forward view, or to the standard forward-view (SF) group, in which the right-sided colon was examined once in the forward view. The primary outcome was the right-sided ADR on RF examination of the right-sided colon. RESULTS: A total of 640 subjects completed the study protocol (RF group, n = 320; SF group, n = 320). The right-sided ADR in the RF group was significantly higher than that in the SF group (17.5% vs 11.9%, respectively; P = 0.044). In the RF group, an additional 31 adenomas were found, resulting in an increased detection rate of adenomas of 38.3% compared with the first forward view. The ADR of the whole colon was similar between the groups. CONCLUSIONS: In our prospective randomized controlled trial, RF examination of the right-sided colon, which can be easily performed in clinical practice, was associated with an increased rate of detection of right-sided ADR.

HER2 as a potential biomarker of lymph node metastasis in undifferentiated early gastric cancer.

Human epidermal growth factor receptor 2 (HER2) is implicated in several cancers, including gastric cancer. However, limited data are available regarding its clinical significance in early gastric cancer (EGC). We evaluated the clinical significance of HER2 overexpression in patients with EGC. We retrospectively reviewed 727 patients who underwent surgical treatment for EGC between October 2010 and August 2017. HER2 expression was analysed in 680 EGC cases by immunohistochemistry and classified as negative (0 and 1+), equivocal (2+), or positive [overexpression (3+)]. Among patients with differentiated EGC, the number of patients with HER2 overexpression was not significantly different from that of HER2-negative patients in terms of age, sex, tumour size, location, gross type, depth of invasion, presence of lymphovascular invasion (LVI), and presence of lymph node metastasis (LNM). However, in patients with undifferentiated EGC, HER2 overexpression was significantly correlated with LVI and presence of LNM compared with HER2-negative patients. Multivariate analysis indicated HER2 overexpression as a good predictive marker of LNM in patients with undifferentiated EGC. HER2 expression is associated with LNM in undifferentiated EGC. Therefore, the importance of HER2 overexpression in EGC should not be overlooked, and further studies are needed to identify its clinical significance.