Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study.

BACKGROUND: Proton-pump inhibitors (PPIs) are the most effective drugs for treating acid-related disorders. However, once-daily dosing with conventional PPIs fail to fully control acid secretion over 24 h. This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE). METHODS: We enrolled 213 patients with EE randomized in a 1:1 ratio to receive 40 mg HIP1601 (n = 107) or HGP1705 (n = 106) once daily for 4 or 8 weeks. The primary endpoint was the EE healing rate, confirmed by endoscopy up to week 8. GERD-related symptoms and treatment-emergent adverse events were compared between both groups. RESULTS: By week 8, the estimated healing rates of EE were 97.8% and 96.8% in the HIP1601 and HGP1705 groups, respectively, with a 95% confidence interval of -4.7 to 7.2. After 4 or 8 weeks of treatment, the EE healing rate at week 4, complete resolution rate of symptoms, time to sustained resolution of symptoms, and number of rescue medications used were similar in both groups. The proportion of heartburn- and acid regurgitation-free nights by week 4 were higher in the HIP1601 group compared to the HGP1705 group, but the difference did not reach clinical significance (87.7% vs. 85.8%, P = 0.514, 87.5% vs. 85.8%, P = 0.774). The number of adverse events did not differ significantly between the two groups. CONCLUSIONS: The efficacy and safety of HIP1601 40 mg were comparable to those of HGP1705 40 mg for the treatment of EE and symptomatic improvement of GERD. TRIAL REGISTRATION: NCT04080726 ( https://classic. CLINICALTRIALS: gov/ct2/show/NCT04080726 ), registration date: 25/10/2018.

Endoscopic Intervention for Anastomotic Leakage After Gastrectomy.

Anastomotic leaks and fistulas are significant complications of gastric surgery that potentially lead to increased postoperative morbidity and mortality. Surgical intervention is reserved for cases with severe symptoms or hemodynamic instability; however, surgery carries a higher risk of complications. With advancements in endoscopic treatment options, endoscopic approaches have emerged as the primary choice for managing these complications. Endoscopic clipping is a traditional method comprising 2 main categories: through-the-scope clips and over-the-scope clips. Through-the-scope clips are user friendly and adaptable to various clinical scenarios, whereas over-the-scope clips can close larger defects. Another promising approach is endoscopic stent insertion, which has shown a high success rate for leak closure, although vigilant monitoring is required to monitor stent migration. Infection control is essential in post-surgical leakage cases, and endoscopic internal drainage provides a relatively safe and noninvasive means to manage fluids, contributing to infection control and wound healing promotion. Endoscopic suturing offers full-thickness wound closure, but requires additional training and endoscopic versatility. As a promising tool, endoscopic vacuum therapy potentially surpasses stent therapy by draining inflammatory materials and closing defects. Furthermore, the use of tissue sealants, such as fibrin glue and cyanoacrylate, has been reported to be effective in selected situations. The choice of endoscopic device should be tailored to individual cases and specific patient conditions, with careful consideration of the nature of the defect. Further extensive studies involving larger patient populations are required to provide more robust evidence on the efficacy of endoscopic approach in managing post-gastric anastomotic leaks.

Enhanced multi-class pathology lesion detection in gastric neoplasms using deep learning-based approach and validation.

This study developed a new convolutional neural network model to detect and classify gastric lesions as malignant, premalignant, and benign. We used 10,181 white-light endoscopy images from 2606 patients in an 8:1:1 ratio. Lesions were categorized as early gastric cancer (EGC), advanced gastric cancer (AGC), gastric dysplasia, benign gastric ulcer (BGU), benign polyp, and benign erosion. We assessed the lesion detection and classification model using six-class, cancer versus non-cancer, and neoplasm versus non-neoplasm categories, as well as T-stage estimation in cancer lesions (T1, T2-T4). The lesion detection rate was 95.22% (219/230 patients) on a per-patient basis: 100% for EGC, 97.22% for AGC, 96.49% for dysplasia, 75.00% for BGU, 97.22% for benign polyps, and 80.49% for benign erosion. The six-class category exhibited an accuracy of 73.43%, sensitivity of 80.90%, specificity of 83.32%, positive predictive value (PPV) of 73.68%, and negative predictive value (NPV) of 88.53%. The sensitivity and NPV were 78.62% and 88.57% for the cancer versus non-cancer category, and 83.26% and 89.80% for the neoplasm versus non-neoplasm category, respectively. The T stage estimation model achieved an accuracy of 85.17%, sensitivity of 88.68%, specificity of 79.81%, PPV of 87.04%, and NPV of 82.18%. The novel CNN-based model remarkably detected and classified malignant, premalignant, and benign gastric lesions and accurately estimated gastric cancer T-stages.

Risk Assessment of Metachronous Gastric Neoplasm after Endoscopic Resection for Early Gastric Cancer According to Age at Helicobacter pylori Eradication.

Background/Aims: Helicobacter pylori eradication can reduce the incidence of metachronous gastric neoplasm (MGN) after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). This study evaluated the risk of developing MGN after ESD for EGC based on age at H. pylori eradication. Methods: Data of patients who underwent curative ESD for EGC with H. pylori infection between 2005 and 2018 were retrospectively analyzed. The patients were allocated to four groups according to age at H. pylori eradication: group 1 (<50 years), group 2 (50-59 years), group 3 (60-69 years), and group 4 (≥70 years). Results: All patients were followed up for at least 5 years after ESD. The 5-year cumulative incidence of MGN was 2.1%, 7.0%, 8.7%, and 16.7% in groups 1, 2, 3, and 4, respectively (p<0.001), and groups 3 and 4 showed a significant increase in the risk of MGN (hazard ratio [HR], 4.66; 95% confidence interval [CI], 1.09 to 19.92 and HR, 10.75; 95% CI, 2.45 to 47.12). After adjustments for moderate to severe intestinal metaplasia based on the updated Sydney system, groups 3 and 4 remained significantly associated with MGN (HR, 4.40; 95% CI, 1.03 to 18.84 and HR, 10.14; 95% CI, 2.31 to 44.57). Conclusions: The incidence of MGN after ESD for EGC increased with age at H. pylori eradication. Age at H. pylori eradication ≥60 years was an independent risk factor for MGN, even after adjusting for the presence of advanced intestinal metaplasia.

Clinical outcomes of ablation of gastric dysplasia with argon plasma coagulation.

BACKGROUND: Although several small cohort studies have shown the utility of argon plasma coagulation (APC) in the treatment of gastric dysplasia, its clinical significance has not been established. This study aims to assess the efficacy of APC as a first line treatment for gastric dysplasia, and identify risk factors for residual dysplasia. METHODS: A total of 179 cases of gastric dysplasia were treated with APC and have been followed-up with upper endoscopy within 1 year. The overall incidence and the characteristics of lesions with residual dysplasia in follow-up endoscopy were analyzed by logistic regression. RESULTS: Among 179 lesions treated with APC, 171 (95.5%) lesions have achieved complete ablation in the follow-up endoscopy. Additional APC was applied for residual dysplasia, achieving complete ablation in 97.77% (175/179). The upper third location of the gastric dysplasia was significantly associated with residual dysplasia, while tumor size, horizontal location, macroscopic morphology and grade of dysplasia showed no significant associations with residual dysplasia following the initial APC. CONCLUSIONS: APC with meticulous follow-up can be recommended as a first line treatment in patients with gastric dysplasia.

The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study.

Background/Aims: : Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers. Methods: : Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed. Results: : One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups. Conclusions: : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.