A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease

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).

Comparison Trial between I-SCAN-Optical Enhancement and Chromoendoscopy for Evaluating the Horizontal Margins of Gastric Epithelial Neoplasms

Background/Aims@#Endoscopic submucosal dissection is a widely used treatment for gastric epithelial neoplasms. Accurate delineation of the horizontal margins is necessary for the complete resection of gastric epithelial neoplasms. Recently, image-enhanced endoscopy has been used to evaluate horizontal margins of gastric epithelial neoplasms. The aim of this study was to investigate whether I-SCAN-optical enhancement (I-SCAN-OE) is superior to chromoendoscopy in evaluating the horizontal margin of gastric epithelial neoplasms. @*Methods@#This was a multicenter, prospective, and randomized trial. The participants were divided into two groups: I-SCAN-OE and chromoendoscopy. For both groups, we first evaluated the horizontal margins of early gastric cancer or high-grade dysplasia using white-light imaging, and then evaluated, the horizontal margins using I-SCAN-OE or chromoendoscopy. We devised a unique scoring method based on the pathological results obtained after endoscopic submucosal dissection to accurately evaluate the horizontal margins of gastric epithelial neoplasms. The delineation scores of both groups were compared, as were the ratios of positiveegative horizontal margins. @*Results@#In total, 124 patients were evaluated for gastric epithelial neoplasms, of whom 112 were enrolled in the study. A total of 112 patients participated in the study, and 56 were assigned to each group (1:1). There was no statistically significant difference in the delineation scores between the groups (chromoendoscopy, 7.80±1.94; I-SCAN-OE, 8.23±2.24; p=0.342). @*Conclusions@#I-SCAN-OE did not show superiority over chromoendoscopy in delineating horizontal margins of gastric epithelial neoplasms.

Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis

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).

Gastric Ectopic Pyloric Opening with Gastric Ulcer: A Rare Case / 대한소화기학회지

The stomach temporarily stores food and secretes gastric juices to break down and digest food. The normal process is the movement of food digested from the stomach to the duodenum, with the pylorus as a passageway. This paper reports the case of a patient with an ectopic gastric pylorus who presented with gastrointestinal bleeding. A 62-year-old man complained of melena with mild dizziness and nausea. An endoscopic examination revealed a gastric ulcer, approximately 1 cm in diameter, and exposed blood vessels on the posterior wall of the upper body. No normal pyloric structure was observed in the distal antrum, and an opening leading to the duodenum was noted in the posterior wall of the upper body adjacent to the ulcer. This case presents a congenital pyloric ectopic opening in the upper body of the stomach, not in the distal antrum, suggesting a rare gastric morphological variation.

Practice Patterns for Eosinophilic Esophagitis Patients in Busan and Gyeongnam: A Korean Multicenter Database Study

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.

Diode Laser—Can It Replace the Electrical Current Used in Endoscopic Submucosal Dissection? (with Video)

Background/Aims@#A new medical fiber-guided diode laser system (FDLS) is expected to offer high-precision cutting with simultaneous hemostasis. Thus, this study aimed to evaluate the feasibility of using the 1,940-nm FDLS to perform endoscopic submucosal dissection (ESD) in the gastrointestinal tract of an animal model. @*Methods@#In this prospective animal pilot study, gastric and colorectal ESD using the FDLS was performed in ex vivo and in vivo porcine models. The completeness of en bloc resection, the procedure time, intraprocedural bleeding, histological injuries to the muscularis propria (MP) layer, and perforation were assessed. @*Results@#The en bloc resection and perforation rates in the ex vivo study were 100% (10/10) and 10% (1/10), respectively; those in the in vivo study were 100% (4/4) and 0% for gastric ESD and 100% (4/4) and 25% (1/4) for rectal ESD, respectively. Deep MP layer injuries tended to occur more frequently in the rectal than in the gastric ESD cases, and no intraprocedural bleeding occurred in either group. @*Conclusions@#The 1,940-nm FDLS was capable of yielding high en bloc resection rates without intraprocedural bleeding during gastric and colorectal ESD in animal models.

Diode Laser—Can It Replace the Electrical Current Used in Endoscopic Submucosal Dissection? (with Video)

Background/Aims@#A new medical fiber-guided diode laser system (FDLS) is expected to offer high-precision cutting with simultaneous hemostasis. Thus, this study aimed to evaluate the feasibility of using the 1,940-nm FDLS to perform endoscopic submucosal dissection (ESD) in the gastrointestinal tract of an animal model. @*Methods@#In this prospective animal pilot study, gastric and colorectal ESD using the FDLS was performed in ex vivo and in vivo porcine models. The completeness of en bloc resection, the procedure time, intraprocedural bleeding, histological injuries to the muscularis propria (MP) layer, and perforation were assessed. @*Results@#The en bloc resection and perforation rates in the ex vivo study were 100% (10/10) and 10% (1/10), respectively; those in the in vivo study were 100% (4/4) and 0% for gastric ESD and 100% (4/4) and 25% (1/4) for rectal ESD, respectively. Deep MP layer injuries tended to occur more frequently in the rectal than in the gastric ESD cases, and no intraprocedural bleeding occurred in either group. @*Conclusions@#The 1,940-nm FDLS was capable of yielding high en bloc resection rates without intraprocedural bleeding during gastric and colorectal ESD in animal models.

Acquired Hemophilia A with Gastrointestinal Bleeding

Peptic ulcer disease is the most common cause of acute gastrointestinal bleeding, followed by variceal bleeding, Mallory–Weiss syndrome, and malignancy. On the contrary, acquired hemophilia A is a very rare hemorrhagic disease, which usually manifests with musculocutaneous bleeding, caused by autoantibodies against coagulation factor VIII. A 78-year-old man presented to the Emergency Department with melena. Dieulafoy’s lesions were observed on esophagogastroduodenoscopy, and endoscopic cauterization was performed. However, the patient complained of back pain and symptoms indicative of upper gastrointestinal bleeding. Abdominopelvic computed tomography was performed, and hematoma in the psoas muscle was detected. Antibodies against coagulation factor VIII were confirmed with a blood test, and the diagnosis of acquired hemophilia A was made. Here, we report a case of acquired hemophilia A presenting with upper gastrointestinal bleeding symptoms and present a brief review of literature.

Pneumothorax Following Gastric Endoscopic Mucosal Resection / 대한소화기학회지

An endoscopic mucosal resection (EMR) is used widely as an alternative treatment to a surgical resection for early gastric neoplasticlesions. Among the unusual complications of gastric EMR, perforation is usually manifested as a pneumoperitoneum. Thispaper reports a patient with a left-side pneumothorax without pneumoperitoneum as a complication of gastric EMR. The patientdeveloped a left side pneumothorax after gastric EMR in the gastric fundus and recovered without further complications afterconservative treatment, including endoscopic clipping.

Endoscopic Diagnosis of Aortoesophageal Fistula Not Presenting Hematemesis / 대한소화기학회지

Aortoesophageal fistula (AEF) is an extremely rare but lethal cause of massive gastrointestinal hemorrhage. Characteristic symptoms are mid-thoracic pain, sentinel minor hemorrhage, and massive hemorrhage after a symptom-free interval. Prompt diagnosis and immediate treatments are necessary to reduce mortality. However, AEF is difficult to diagnose because it is uncommon and often leads to death with massive bleeding before proper evaluation. We report a case of endoscopic diagnosis of AEF that did not present with hematemesis; it was treated with thoracic endovascular aortic repair (TEVAR) and surgery. A 71-year-old female presented to the emergency department with epigastric discomfort. Endoscopy demonstrated a submucosal tumor-like protrusion and pulsating mass with blood clots. Contrast-enhanced chest CT confirmed AEF due to descending thoracic aortic aneurysm. The patient immediately underwent TEVAR to prevent massive bleeding and subsequently underwent surgery. Endoscopists should consider AEF if they see a submucosal tumor-like mass with a central ulcerative lesion or a pulsating protrusion covered with blood clots in mid-esophagus during an endoscopy.

Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia: A Randomized, Controlled Trial

BACKGROUND/AIMS: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). METHODS: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. RESULTS: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were 9.69±6.44 and 10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, 1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. CONCLUSIONS: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

Treatment of Early Gastric Cancer: Endoscopic Submucosal Dissection with LASER / 대한내과학회지

In 2000, endoscopic resection is very useful treatment modality for early gastric cancer. The Needle Knife (Olympus, Tokyo, Japan) and Insulated Tip Knife (Olympus) are used for endoscopic dissection of gastrointestinal tumors in clinical practice. The depth of penetration and the high power delivered to soft tissue by electrocautery with these needles are not well controlled, and therefore may increase the risk of complications such as intestinal perforation and bleeding lasers 2-µm in wavelength offer efficient tissue cutting with limited thermal damage in biological tissue. Light amplication by the sumulated emission of radiation dissection demonstrated good maneuverability, clean and rapid cutting, and excellent hemostasis. And, now we would like to evaluate the clinical outcomes of the endoscopic submucosal dissection with using laser and capabilities in the future.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was −0.4% (95% confidence interval, −9.8% to 9.1%), which was above the non-inferiority margin of −14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670)

Helicobacter pylori-negative Gastric Cancer

Although Helicobacter pylori is considered the main etiological factor in gastric cancer, at least 5.4% of gastric cancer cases in South Korean patients are H. pylori-negative. However, false-negative H. pylori results should be considered. The definitions of H. pylori status in patients with atrophic gastritis but negative tests for H. pylori are variable. Inaccurate H. pylori detection systems can interfere with interpretation of the results. Even when H. pylori has been eradicated, gastric atrophy and intestinal metaplasia resulting from long-term colonization can occur. It is very difficult to determine whether patients with gastric cancer, who frequently have advanced gastric atrophy and intestinal metaplasia, have had previous H. pylori infection based on invasive tests. In addition, H. pylori-negative gastric cancers present with a more advanced pT classification and a more advanced stage than H. pylori-positive gastric cancers. Negative H. pylori status appears to be an indicator of poor prognosis in patients with gastric cancer, and is independent of other well-known clinical and pathologic prognostic variables.

Eosinophilic Gastritis Presenting as Tissue Necrosis

Eosinophilic gastroenteritis is very rare disorder that is characterized by eosinophilic infiltration of the gastrointestinal tract in the absence of any definite causes of eosinophilia. It is associated with various clinical gastrointestinal manifestations, and depends on the involved layer and site. We report a case of eosinophilic gastritis presenting with severe necrosis. The symptoms disappeared immediately after beginning steroid treatment, and the eosinophil count decreased to the reference range. The patient showed eosinophilic gastritis characterized by necrotic change such as necrotizing gastritis. It is a unique presentation of eosinophilic gastritis. To the best of our knowledge, no case of eosinophilic gastritis characterized by necrotic change such as necrotizing gastritis has been previously reported in Korea.

A Case of Aspiration Pneumonia after Upper Gastrointestinal Endoscopy

In upper gastrointestinal endoscopy, intravenous anesthesia is commonly used due to its safety and improvement in patient's satisfaction and comfort. The aim of this approach is to improve the condition for endoscopy. Although the risks of sedation are reported to be very low with sufficient monitoring, we still have few risks that cannot be overlooked including aspiration pneumonia. There have been two reported cases of aspiration pneumonia after endoscopic submucosal dissection. However, to our knowledge, there has been no reports about aspiration pneumonia developing after endoscopy for a young healthy female. So, we report a first case of unexpected aspiration pneumonia after endoscopy.

A Case of Peutz-Jeghers Syndrome with Small Bowel Neuroendocrine Carcinoma / 대한내과학회지

Peutz-Jeghers syndrome (PJS) is an autosomal dominant inherited disorder characterized by hamartomatous polyps in the gastrointestinal tract and mucocutaneous melanin pigmentation. Hamartomas are not generally regarded as premalignant, although patients with PJS are at increased risk for common and unusual types of gastrointestinal and non-gastrointestinal malignancies. However, most of the reported gastrointestinal malignancies have been adenocarcinomas, and few reports of an association of this syndrome with a neuroendocrine tumor (NET) have been published. Moreover, no case of this syndrome with NET has been reported in Korea. Here, we report a 21-year old male with PJS who had a small bowel neuroendocrine carcinoma.

A comparison of the BISAP score and serum procalcitonin for predicting the severity of acute pancreatitis

BACKGROUND/AIMS: The bedside index of severity in acute pancreatitis (BISAP) is a new, convenient, prognostic multifactorial scoring system. As more data are needed before clinical application, we compared BISAP, the serum procalcitonin (PCT), and other multifactorial scoring systems simultaneously. METHODS: Fifty consecutive acute pancreatitis patients were enrolled prospectively. Blood samples were obtained at admission and after 48 hours and imaging studies were performed within 48 hours of admission. The BISAP score was compared with the serum PCT, Ranson's score, and the acute physiology and chronic health examination (APACHE)-II, Glasgow, and Balthazar computed tomography severity index (BCTSI) scores. Acute pancreatitis was graded using the Atlanta criteria. The predictive accuracy of the scoring systems was measured using the area under the receiver-operating curve (AUC). RESULTS: The accuracy of BISAP (> or = 2) at predicting severe acute pancreatitis was 84% and was superior to the serum PCT (> or = 3.29 ng/mL, 76%) which was similar to the APACHE-II score. The best cutoff value of BISAP was 2 (AUC, 0.873; 95% confidence interval, 0.770 to 0.976; p < 0.001). In logistic regression analysis, BISAP had greater statistical significance than serum PCT. CONCLUSIONS: BISAP is more accurate for predicting the severity of acute pancreatitis than the serum PCT, APACHE-II, Glasgow, and BCTSI scores.

Patient Perception of Natural Orifice Transluminal Endoscopic Surgery in an Endoscopy Screening Program in Korea

PURPOSE: Natural orifice transluminal endoscopic surgery (NOTES) is a new method of accessing intracavitary organs in order to minimize pain by avoiding incisions in the body wall. The aim of this study is to determine patients' acceptance of NOTES in Korea and to compare their views about laparoscopic surgery and NOTES for benign and malignant diseases. MATERIALS AND METHODS: The target number of total subjects was calculated to be 540. The subjects were classified into 18 sub-groups based on age groups, gender, and history of prior surgery. The questionnaire elicited information about demographic characteristics, medical check-ups, diseases, endoscopic and surgical histories, marital status and childbirth, the acceptance of NOTES, and the preferred routes for NOTES. In addition, the subjects chose laparoscopic surgery or NOTES for a hypothetical cholecystectomy and rectal cancer surgery, and responded to questions regarding the acceptable complication rate of NOTES, the appropriate cost of NOTES, and the reason(s) why they did not select NOTES. RESULTS: 486 of 540 patients (90.0%) who agreed to participate in this study completed the questionnaire. NOTES was preferred by the following patients: elderly; a history of treatment due to a disease; having regular check-ups; and a history of an endoscopic procedure (p<0.05). The most preferred route for NOTES was the stomach (67.1%). Eighty-four percent of the patients choosing NOTES responded that the complication rate of the new surgical method should be the same or lower than laparoscopic surgery. Vague anxiety over a new surgical method was the most common reason why NOTES was not selected in benign and malignant diseases (64% and 73%), respectively. CONCLUSION: Patients appear to be interested in the potential benefits of NOTES and would embrace it if their concerns about safety are met. We believe that qualified surgical endoscopists can meet these safety concerns, and that NOTES development has the potential to flourish.

A Case of Synchronous Esophagus and Stomach Cancer Successfully Treated by Combined Chemotherapy / 대한소화기학회지

Although cases of simultaneous esophagus and stomach cancer have been reported sporadically, there are rare reports of successful treatment using chemotherapy. We report a case of synchronous esophageal and gastric cancer successfully treated using docetaxel and cis-diammineedichloro-platinum (CDDP) combination chemotherapy instead of surgery. A 82-years-old man with anorexia and progressive weight loss was diagnosed with synchronous esophageal and gastric cancer by endoscopy. Both cancers were diagnosed as resectable by the preoperative clinical staging. However, surgery was contraindicated because of severe lung dysfunction. Moreover, he actively refused radiotherapy and endoscopic management. Therefore, the patient was given combined chemotherapy with docetaxel (65 mg/m2) and CDDP (60 mg/m2). The esophageal and gastric lesion completely disappeared on endoscopy, and there were no residual tumor cells on endoscopic biopsy after three cycles of chemotherapy. Metastatic lymph nodes also completely disappeared on the CT scan. The patient received a total of ten cycles of chemotherapy, without severe adverse effects. The patient remained asymptomatic for 18 months after discontinuation of the chemotherapy, without evidence of local recurrence or distant metastasis. Surgery or endoscopic treatment of both esophageal and gastric cancers is desirable, but, if medically inoperable, chemotherapy can be alternative treatment option.