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Background/Aims@#Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone. @*Methods@#This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4. @*Results@#A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles. @*Conclusions@#EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
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Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is the most common type of extranodal non-Hodgkin lymphoma. Endoscopic findings are nonspecific and variable; therefore, differentiation of this malignancy from early gastric cancer is challenging during endoscopy. Although an endoscopic biopsy is the gold standard for diagnosis, a biopsy may not conclusively establish the diagnosis in all cases. Diagnostic confirmation requires interpretation of the biopsy specimen findings by an experienced histopathologist, and an additional immunoglobulin heavy chain (IgH) rearrangement test may aid with accurate diagnosis. We present a case of gastric MALT lymphoma that histopathologically mimicked signet ring cell carcinoma (SRCC) on evaluation of repeat endoscopic biopsies. Following endoscopic submucosal dissection (ESD), we confirmed the final diagnosis of gastric MALT lymphoma based on histopathological findings of prominent lymphoid infiltrates accompanied by lymphoepithelial lesions and results of the monoclonal IgH rearrangement test. Notably, a few carcinoma-like signet ring cells (SRCs) in the specimen were attributed to a reactive change. Clinicians should be mindful of possible SRCs in gastric MALT lymphoma specimens to avoid misdiagnosis of SRCC in patients with gastric MALT lymphoma. Confirmatory ESD may be useful for accurate diagnosis and appropriate management of such lesions.
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Recent advances in endoscopic technology, including high-definition and image-enhanced endoscopy such as narrow-band imaging have facilitated close observation and detailed imaging of the gastric mucosa. Currently, endoscopy is performed in Korea primarily for evaluation of premalignant conditions and gastric cancer detection. Recent research has established the Kyoto classification of gastritis, a novel grading system for endoscopic gastritis, which enables prediction of Helicobacter pylori (H. pylori) infection. The Kyoto classification score is calculated based on the sum of scores for five main items (of 19 endoscopic findings indicative of H. pylori infection) such as atrophy, intestinal metaplasia, enlarged gastric folds, nodularity, and diffuse redness with/without regular arrangement of collecting venules (RAC). Of these five endoscopic findings, atrophy, intestinal metaplasia, enlarged gastric folds, and nodularity are associated with an increased risk and RAC with a decreased risk of gastric cancer. Previous studies have reported that a Kyoto classification score ≥2 indicates current or past H. pylori infection. An increase in the Kyoto classification score is associated with a high risk of gastric cancer; specifically, a Kyoto classification score ≥4 indicates a high risk of gastric cancer. However, H. pylori eradication is followed by disappearance of enlarged gastric folds, nodularity, and diffuse redness; therefore, this grading system cannot accurately reflect the gastric cancer risk in patients with previous H. pylori infection. Limited studies have discussed the Kyoto classification of gastritis in Korea. Therefore, further large-scale multicenter studies are warranted for validation of the Kyoto classification to predict H. pylori infection and gastric cancer risk.
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Foreign body ingestion is commonly seen in children. However, occasionally it may also be seen among adults and is often associated with intellectual disability, psychiatric disorders, and alcoholism. Ingestion of a magnetic foreign body may cause complications such as gastrointestinal tract perforation, wherein emergency endoscopic removal of the foreign body is generally required. Here, we report a rare case of a 59-year-old male with an intellectual disability and psychiatric disorder in whom metallic objects in the stomach cavity were accidentally discovered during abdominal CT. Esophagogastroduodenoscopy revealed several metallic objects attached to two magnets, which had been ingested several years before and had remained in the stomach cavity. The magnets and metallic objects were safely removed endoscopically using rat-tooth forceps without complications.
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The fundic gland type (GA-FG) of gastric adenocarcinoma is a rare variant of gastric cancer recently included in the 5th edition of the World Health Organization’s classification of digestive system tumors. Five patients with GA-FG underwent an endoscopic resection at our institution. None of the patients had a Helicobacter pylori infection. Four lesions were located in the upper third of the stomach, and one was in the lower third. Three lesions had a IIa shape, while two resembled a subepithelial tumor. An endoscopic submucosal dissection was performed in four patients and endoscopic mucosal resection in one. Tumor cells were composed of well-differentiated columnar cells mimicking fundic gland cells, and the median tumor size was 10 mm. Three lesions exhibited submucosal invasion. No lymphatic or venous invasion was observed. Tumor cells were positive for MUC6 in all five cases; one case was focally positive for MUC5AC. No recurrence was observed during a median follow-up period of 13 months. An endoscopic resection can be a safe treatment modality for GA-FG, considering its small size and low risk of recurrence or metastasis. (Korean J Gastroenterol 2023;81:259-264)
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Esophageal subepithelial tumors (SETs) are commonly encountered during screening endoscopy, and leiomyomas are the most common SET of the esophagus. Almost all patients with esophageal leiomyomas are asymptomatic; however, some present with dysphagia, depending on the size of the tumor and the extent to which it encroaches on the lumen. The typical endosonographic features of esophageal leiomyomas include well-demarcated, homogeneously hypoechoic lesions with echogenicity similar to that of the surrounding proper muscle layer, but without cystic changes. Histopathologically, esophageal leiomyomas do not undergo cystic or myxoid degeneration. This report presents a case involving a 65-year-old man with a symptomatic esophageal SET and endosonographic features indicative of malignant neoplasms, who was diagnosed with esophageal leiomyoma with cystic and myxoid degeneration following surgical resection.
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Background/Aims@#Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis. @*Methods@#In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events. @*Results@#Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups.No significant difference was noted in the incidence of adverse drug reactions. @*Conclusions@#Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
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Background/Aims@#Among several methods used to prevent endoscopic submucosal dissection (ESD) bleeding, the recently developed hemostatic powder (HP) has few technical limitations and is relatively easy-to-use. This study aimed to analyze the hemostatic effects and mechanisms of two HPs using a porcine upper gastrointestinal hemorrhage model. @*Methods@#We evaluated HPs (Endospray and epidermal growth factor [EGF]-endospray) for adhesion, waterproofing ability, permeability, and absorption in vitro. ESD was performed to induce bleeding ulcers in the porcine stomachs. In a total of three pigs, three bleeding ulcers per animal were generated. Hemostasis and rebleeding were evaluated endoscopically. After 72 hours, the animals were sacrificed, and histologically analyzed. @*Results@#The water absorption of HPs was over 20 times the initial value within 30 minutes. The gelated HPs completely blocked water penetration into the applied site within 5 minutes and strongly adhered to the Petri-dish surface for up to 6 hours. The initial hemostasis rates within 5 minutes were 33.3%, 100.0%, and 66.7%, and the rebleeding rates at 6 to 72 hours after HP application were 33.3%, 16.7%, and 33.3% (control, Endospray, and EGF-endospray groups, respectively). Histological analysis revealed the thickness of the regenerated mucosa (522.1, 514.5, and 680.3 µm) and the submucosal layer (1,510.3, 2,848.2, and 3,062.3 µm) and the number of newly formed blood vessels (15.3, 17.9, and 20.5) in the control, Endospray, and EGFendospray groups, respectively. @*Conclusions@#The endoscopic HPs demonstrated the ability to elicit effective initial hemostasis and the histological ulcer-healing effect of EGF in an animal model of hemorrhagic gastric ulcers.
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Background/Aims@#The eCura system, a scoring model for stratifying the lymph node metastasis risk after noncurative endoscopic resection for early gastric cancer (EGC), has been internally validated, primarily for differentiated-type EGC. We aimed to externally validate this model for undifferentiated-type EGC. @*Methods@#This multicenter, retrospective cohort study included 634 patients who underwent additional surgery (radical surgery group, n=270) or were followed up without additional treatment (no additional treatment group, n=364) after noncurative endoscopic resection for undifferentiated-type EGC between 2005 and 2015. The lymph node metastasis and survival rates were compared according to the risk categories. @*Results@#For the radical surgery group, the lymph node metastasis rates were 2.6%, 10.9%, and 14.8% for the low-, intermediate-, and high-risk eCura categories, respectively (p for trend=0.003). For the low-, intermediate-, and high-risk categories in the no additional treatment group, the overall survival (92.7%, 68.9%, and 80.0% at 5 years, respectively, p<0.001) and cancer-specific survival rates (99.7%, 94.7%, and 80.0% at 5 years, respectively, p<0.001) differed significantly. In the multivariate analysis, the hazard ratios (95% confidence interval) in the no additional treatment group relative to the radical surgery group were 3.18 (1.41 to 7.17; p=0.005) for overall mortality and 2.60 (0.46 to 14.66; p=0.280) for cancer-specific mortality in the intermediate-tohigh risk category. No such differences were noted in the low-risk category. @*Conclusions@#The eCura system can be applied to undifferentiated-type EGC. Close follow-up without additional treatment might be considered for low-risk patients, while additional surgery is recommended for intermediate- and high-risk patients.
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Background/Aims@#This study aimed to evaluate the prevalence and natural progression of subepithelial lesions (SELs) in the upper gastrointestinal (UGI) tract. @*Methods@#The medical records of patients with UGI SELs who underwent endoscopic screening at eight university hospitals between January and December 2010 were retrospectively investigated. The follow-up evaluations were performed until December 2016. @*Results@#UGI SELs were found in 1,044 of the 65,233 participants screened (endoscopic prevalence, 1.60%; the total number of lesions, 1,062; mean age, 55.1±11.2 years; men, 53.6%). The median follow-up period was 48 (range, 8–74) months. SELs were most frequently found in the stomach (63.8%) and had a mean size of 9.9±6.1 mm. Endoscopic ultrasonography (EUS) was performed in 293 patients (28.1%). The most common lesions were leiomyomas, followed by gastrointestinal stromal tumors (GISTs), and ectopic pancreas. The proportions of SELs with malignant potential according to size were 3% (<1 cm), 22% (1–2 cm), 27% (2–3 cm), and 38% (≥3 cm). In gastric SELs larger than 1 cm, resections were performed in 20 patients because of an increase in size, of which 12 were found to be GISTs. @*Conclusions@#The prevalence of UGI SELs was 1.60%. Further, 23% of gastric SELs ≥1 cm were precancerous lesions, most followed by EUS and clinical decisions without initial pathological confirmation.
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Background@#Patients with esophageal squamous cell carcinoma (ESCC) have a poor prognosis and there are no effective clinical biomarkers. Recently, stable microRNAs detected in the blood have been suggested as potential biomarkers in various cancers. Therefore, we investigated whether plasma microRNAs could be feasible biomarkers for ESCC. @*Methods@#Peripheral blood samples were obtained from 16 healthy volunteers and 66 ESCC patients before treatment between May 2016 and April 2021. Plasma miR-18b, miR-21, miR-31, and miR-375 expression levels were measured using reverse transcription-quantitative polymerase chain reaction. @*Results@#Compared with those in healthy controls, the expression levels of plasma miR-21 were significantly higher (P = 0.022) and those of plasma miR-31 and miR-375 were significantly lower in ESCC patients (both P < 0.001). Plasma miR-18b expression levels increased in ESCC patients, but the difference was not significant (P = 0.164). The sensitivities and specificities of miR-21, miR-31, and miR-375 for differentiating ESCC patients from healthy controls were 87.5% and 61.9%, 87.5% and 98.4%, and 87.5% and 100%, respectively. There was no difference in expression levels of plasma miR-21, miR-31, and miR-375 according to clinicopathological characteristics of sex, age, tumor size and location, histologic grade, and tumor-node-metastasis stage. @*Conclusion@#Our study demonstrated that plasma miR-21, miR-31, and miR-375 could be potential biomarkers for the diagnosis of ESCC. Particularly, plasma miR-31 and miR-375 showed high sensitivity and specificity for differentiating ESCC patients from healthy controls.
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Among the types of gastric cancer, the proportion of early gastric cancer has shown a steady increase because the national screening programs have been conducted in Korea. Accordingly, the paradigm shift of the treatment procedure from surgical gastrectomy to endoscopic resection for selected early gastric cancer has accelerated recently. For successful treatment of early gastric cancer, early detection is essential to accurately predict the histological type, depth of invasion, and horizontal margins of the tumor.Current Concepts: The diagnosis of early gastric cancer and selection of treatment procedures comprises the following steps: (1) presence diagnosis, (2) qualitative diagnosis, and (3) quantitative diagnosis. Presently, early gastric cancer diagnosis is based on the endoscopic detection of a demarcated lesion and irregularity of the mucosal surface or color pattern. If a lesion is diagnosed as early gastric cancer, qualitative and quantitative diagnostic processes should be conducted. Qualitative diagnosis predicts the histological type (differentiated vs. undifferentiated), whereas quantitative diagnosis predicts the invasion depth and horizontal margins of the lesion. The diagnostic processes are based on the macroscopic morphology and color of the lesion, while sometimes using chromoendoscopy, image-enhanced endoscopy, and magnifying endoscopy.Discussion and Conclusion: If gastric cancer is detected at an early stage, most cases can be treated only by endoscopic resection. Therefore, endoscopists should have systematic knowledge regarding the findings of early gastric cancer for timely detection and appropriate selection of the treatment procedure.
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Background/Aims@#Endoscopic ultrasonography (EUS) provides high-resolution images and is superior to computed tomography (CT) scan in diagnosing small pancreatic ductal adenocarcinoma (PDAC). As a result, the use of EUS for early detection of PDAC has attracted attention. This study aimed to identify the clinical and radiological characteristics of patients with PDAC diagnosed by EUS but not found on CT scan. @*Methods@#The medical records of patients diagnosed with PDAC at 12 tertiary referral centers in Korea from January 2003 to April 2019 were reviewed. This study included patients with pancreatic masses not clearly observed on CT scan but identified on EUS. The clinical characteristics and radiological features of the patients were analyzed, and survival analysis was performed. @*Results@#A total of 83 patients were enrolled. The most common abnormal CT findings other than a definite mass was pancreatic duct dilatation, which was identified in 61 patients (73.5%). All but four patients underwent surgery. The final pathologic stages were as follows: IA (n=31, 39.2%), IB (n=8, 10.1%), IIA (n=20, 25.3%), IIB (n=17, 21.5%), III (n=2, 2.5%), and IV (n=1, 1.4%). The 5-year survival rate of these patients was 50.6% (95% confidence interval, 38.8% to 66.7%). Elevated liver function testing and R1 resection emerged as significant predictors of mortality in the multivariable Cox regression analysis. @*Conclusions@#This multicenter study demonstrated favorable long-term prognosis in patients with PDAC diagnosed by EUS but indeterminate on CT scan. EUS should be considered for patients with suspected PDAC but indeterminate on CT scan.
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Subepithelial tumors (SETs) are commonly encountered during upper gastrointestinal endoscopy, especially during national gastric cancer screening programs in Korea. Although the majority of SETs are benign, endoscopists harbor concerns regarding whether a SET is benign or malignant because the diagnosis cannot be established on the basis of routine endoscopic biopsy findings. The differential diagnosis of SETs is important, beginning with meticulous endoscopic examination, including the evaluation of the location, macroscopic shape, color, surface characteristics, mobility, consistency, and size of the tumors. The yield of endoscopic biopsy increases with the use of the bite-on-bite technique for SETs without the rolling or tenting sign, with large openings, and with erosion or ulceration. In this review, a systematic approach for the diagnosis of gastric SETs during conventional endoscopy is introduced.
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Paneth cell carcinoma is a rare carcinoma composed predominantly or purely of malignant Paneth cells. An 83-year-old woman presented for evaluation of an elevated lesion in the stomach. On endoscopy, a 15 mm, discolored, elevated lesion with a central depression was found on the greater curvature of the gastric lower body. Endoscopic forceps biopsy revealed chronic gastritis with intestinal metaplasia. Magnifying endoscopy revealed an irregularly oval/tubular microsurface pattern and an irregular loop microvascular pattern with a demarcation line, suggestive of early gastric cancer. Therefore, endoscopic submucosal dissection was performed. Histopathological examination revealed a well-differentiated tubular adenocarcinoma limited to the muscularis mucosae and the tumor cells contained coarse eosinophilic granules in the cytoplasm. These tumor cells were diffusely and strongly stained for lysozyme, confirming the tumor diagnosis as Paneth cell carcinoma. Herein, we report a rare case of Paneth cell carcinoma and its endoscopic and histopathologic findings.
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Percutaneous balloon dilation with or without placement of an external biliary drain is a nonoperative alternative method for treating benign bilioenteric anastomotic strictures. Although this procedure has a high technical success rate, outcomes are less optimal when attempting to dilate refractory tight strictures. For the stricture, cutting balloon can be an option. We present four patients with benign bilioenteric anastomotic strictures refractory to conventional balloon dilation. To the patients, a peripheral cutting balloon over-the-wire system was inflated, following subsequent conventional non-compliant balloon dilation. After the balloon dilation treatment, an external drainage catheter was placed through the stricture site and maintained for up to 30 days. Technical and end-treatment success was achieved in all four patients. In conclusion, the use of cutting balloon dilation may appear to be a safe and effective alternative method of treatment in patients with benign bilioenteric anastomotic strictures refractory to conventional balloon dilation.
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Background/Aims@#The prevalence of eosinophilic esophagitis is increasing in Korea and there are few single-center studies regarding eosinophilic esophagitis in Korea. In particular, data about management for eosinophilic esophagitis are lacking. We aim to evaluate the practice patterns, including initial treatment and response, in the Busan city and Gyeongnam province area. @*Methods@#We retrospectively reviewed medical records to gain data on patient characteristics, medication, endoscopic images, and esophageal biopsy results. From January 2009 to December 2019, a total of 42 patients were diagnosed with eosinophilic esophagitis. @*Results@#The mean age was 50.7 (from 22 to 81) years and the cohort was predominantly male (78.6%, 33/42). The proton pump inhibitor was the preferred treatment as an initial trial for 64.3% (27/42) of patients, followed by swallowed topical steroids (16.7%, 7/42).Clinical improvement after proton pump inhibitor therapy was achieved in 88.9% (24/27) of patients. Two patients who did not achieve improvement showed a clinical and endoscopic response after swallowed topical steroids treatment. No patient received diet elimination or balloon dilatation therapy. @*Conclusions@#The treatment response of eosinophilic esophagitis was good in Busan city and Gyeongnam province area in Korea. Proton pump inhibitor therapy was the preferred and most effective treatment for eosinophilic esophagitis as the initial therapy.
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Purpose@#While the incidence of Barrett’s neoplasia has been increasing in Western countries, the disease remains rare in Asian countries. Therefore, very few studies have investigated the endoscopic treatment for Barrett’s neoplasia in Korea. Endoscopic submucosal dissection (ESD) enables en bloc and complete resection of gastrointestinal neoplastic lesions. This study aimed to evaluate the therapeutic outcomes of ESD for Barrett’s neoplasia in a single center in Korea and to examine the predictive factors for incomplete resection. @*Materials and Methods@#We conducted a retrospective observational study of 18 patients who underwent ESD for superficial Barrett’s neoplasia (dysplasia and early cancer) between January 2010 and December 2019 at Pusan National University Hospital. The therapeutic outcomes of ESD and procedure-related complications were analyzed. @*Results@#En bloc resection, complete resection, and curative resection were performed in 94%, 72%, and 61% of patients, respectively. Histopathology (submucosal or deeper invasion of the tumor) was a significant predictive factor for incomplete resection (P=0.047). Procedure-related bleeding and stenosis were not observed, whereas perforation occurred in one case. During the median follow-up period of 12 months (range, 6–74 months), local recurrence occurred in 2 patients with incomplete resection, one patient underwent repeat ESD, and the other patient received concurrent chemoradiotherapy. The 3-year overall and disease-specific survival rates were 73% and 93%, respectively. @*Conclusions@#ESD seems to be an effective and safe treatment for superficial Barrett’s neoplasia in Korea. Nevertheless, the suitability of ESD for Barrett’s cancer cases should be determined considering the high risk of deep submucosal invasion.
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Early gastric cancers (EGCs) are defined as gastric cancers confined to the mucosa or submucosa, regardless of regional lymph node metastasis. The proportion of EGCs has been increasing due to the increase in screening endoscopy for gastric cancers; therefore, the paradigm shift from surgical resection to endoscopic resection as a treatment modality for selected EGCs is accelerating. For successful endoscopic resection of EGCs, it is important to detect EGCs at an early stage and to accurately predict the histological type, depth of invasion, and horizontal margins of the tumor. The diagnostic process of EGCs can be divided into three steps: presence diagnosis, qualitative diagnosis, and quantitative diagnosis. The presence diagnosis of EGCs is mainly based on two endoscopic findings: a well-demarcated lesion and irregularity in the color/surface pattern. Qualitative diagnosis refers to the prediction of histological type, which is mainly possible based on the macroscopic shape and color of the lesion. Quantitative diagnosis of EGCs consists of predicting the depth of invasion by detailed examination of the macroscopic morphology and determining horizontal margins using chromoendoscopy. Although advanced diagnostic modalities, such as endosonography or magnifying endoscopy, are helpful for the qualitative and quantitative diagnosis of EGCs, these modalities are not available in most hospitals. Therefore, it is still very important to evaluate EGCs systematically during conventional endoscopy for successful endoscopic treatment.
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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.