Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, 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.

Difficult Biliary Cannulation from the Perspective of PostEndoscopic Retrograde Cholangiopancreatography Pancreatitis:Identifying the Optimal Timing for the Rescue Cannulation Technique

Background/Aims@#Recently, the European Society of Gastrointestinal Endoscopy (ESGE) proposed criteria for “difficult biliary cannulation” during endoscopic retrograde cholangiopancreatography (ERCP). This study aimed to investigate the clinical relevance of the ESGE criteria from the perspective of post-ERCP pancreatitis (PEP). @*Methods@#An ERCP database was prospectively maintained between November 2014 and December 2015 across six teaching hospitals in South Korea. The ESGE criteria (biliary cannulation time, the number of cannulation attempts, and inadvertent pancreatic duct [PD] manipulation) were recorded in this database as well as other technical factors. Logistic regression analysis was used to identify risk factors for PEP. Then, the PEP prediction model was investigated using decision tree analysis. @*Results@#We analyzed 1,067 consecutive patients with naïve papilla. The overall rate of PEP was 6.6%. Multivariate analysis revealed that female sex (odds ratio [OR], 1.860; 95% confidence interval [CI], 1.124 to 3.078), a selective biliary cannulation duration >5 minutes (OR, 3.282; 95% CI, 1.641 to 6.566), and inadvertent PD manipulation (OR, 2.614; 95% CI, 1.480 to 4.617) were significant factors affecting PEP. Decision tree analysis revealed that biliary cannulation time (χ2 =49.857, p5 minutes, and >5 minutes with inadvertent PD manipulation, respectively. @*Conclusions@#Biliary cannulation time and inadvertent PD manipulation could be relevant indicators of PEP, and 5 minutes might be used as a cutoff value for the implementation of the rescue cannulation technique.

Difficult Biliary Cannulation from the Perspective of PostEndoscopic Retrograde Cholangiopancreatography Pancreatitis:Identifying the Optimal Timing for the Rescue Cannulation Technique

Background/Aims@#Recently, the European Society of Gastrointestinal Endoscopy (ESGE) proposed criteria for “difficult biliary cannulation” during endoscopic retrograde cholangiopancreatography (ERCP). This study aimed to investigate the clinical relevance of the ESGE criteria from the perspective of post-ERCP pancreatitis (PEP). @*Methods@#An ERCP database was prospectively maintained between November 2014 and December 2015 across six teaching hospitals in South Korea. The ESGE criteria (biliary cannulation time, the number of cannulation attempts, and inadvertent pancreatic duct [PD] manipulation) were recorded in this database as well as other technical factors. Logistic regression analysis was used to identify risk factors for PEP. Then, the PEP prediction model was investigated using decision tree analysis. @*Results@#We analyzed 1,067 consecutive patients with naïve papilla. The overall rate of PEP was 6.6%. Multivariate analysis revealed that female sex (odds ratio [OR], 1.860; 95% confidence interval [CI], 1.124 to 3.078), a selective biliary cannulation duration >5 minutes (OR, 3.282; 95% CI, 1.641 to 6.566), and inadvertent PD manipulation (OR, 2.614; 95% CI, 1.480 to 4.617) were significant factors affecting PEP. Decision tree analysis revealed that biliary cannulation time (χ2 =49.857, p5 minutes, and >5 minutes with inadvertent PD manipulation, respectively. @*Conclusions@#Biliary cannulation time and inadvertent PD manipulation could be relevant indicators of PEP, and 5 minutes might be used as a cutoff value for the implementation of the rescue cannulation technique.

Oxaliplatin-induced Sudden Hearing Loss in a Patient with Pancreatic Cancer / 대한소화기학회지

Oxaliplatin is a new generation of platinum derivatives used frequently to treat solid organ malignancies, including colorectal and ovarian cancer. Recently, an oxaliplatin-based chemotherapeutic regimen was adopted for advanced pancreatic cancer. Although oxaliplatin has extensive therapeutic potential, its use can be limited by significant adverse effects, particularly ototoxicity. This paper reports a rare case of irreversible unilateral hearing loss in a 48-year-old female that developed after the intravenous infusion of oxaliplatin during pancreatic cancer treatment. To the best of the authors’ knowledge, this is the second reported case of oxaliplatin-related ototoxicity in pancreatic cancer.

Impact of Hospital Volume and the Experience of Endoscopist on Adverse Events Related to Endoscopic Retrograde Cholangiopancreatography:A Prospective Observational Study

Background/Aims@#Few studies have addressed the relationship between the occurrence of adverse events (AEs) in endoscopic retrograde cholangiopancreatography (ERCP) and hospital case volume or endoscopist’s experience with inconsistent results. The aim of our study was to investigate the impact of hospital case volume and endoscopist’s experience on the AEs associated with ERCP and to analyze patient- and procedure-related risk factors for post-ERCP AEs. @*Methods@#From January 2015 to December 2015, we prospectively enrolled patients with naïve papilla who underwent ERCP at six centers. Patient- and procedure-related variables were recorded on data collection sheets at the time of and after ERCP. @*Results@#A total of 1,191 patients (median age, 71 years) were consecutively enrolled. The overall success rate of biliary cannulation was 96.6%. Overall, 244 patients (20.5%) experienced post-ERCP AEs, including pancreatitis (9.0%), bleeding (11.8%), perforation (0.4%), cholangitis (1.2%), and others (0.9%). While post-ERCP pancreatitis (PEP) was more common when the procedure was performed by less experienced endoscopists, bleeding was more common in high-volume centers and by less experienced endoscopists. Multivariate analysis showed that a less experience in ERCP was significantly associated with PEP (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.050 to 2.531; p=0.030) and post-ERCP bleeding (OR, 1.439; 95% CI, 1.003 to 2.062; p=0.048). @*Conclusions@#Our study demonstrated that overall AEs following ERCP were associated with the experience of the endoscopist. To minimize post-ERCP AEs, rigorous training with a sufficient case volume is required, and treatment strategies should be modified according to the endoscopist’s expertise.

Clinical characteristics of coronavirus disease 2019 patients with diarrhea in Daegu

Background/Aims@#Coronavirus disease 2019 (COVID-19) can reportedly cause gastrointestinal symptoms. Therefore, we investigated the clinical characteristics of COVID-19 patients with diarrhea. @*Methods@#We included 118 COVID-19 patients admitted to a single hospital from February 20 to March 31, 2020. Medical records with clinical characteristics, laboratory data, treatment course, and clinical outcomes were compared based on the presence or absence of diarrhea. Prognostic factors for disease severity and mortality in COVID-19 were also assessed. @*Results@#Among patients, 54 (45.8%) had diarrhea, whereas seven (5.9%) had only diarrhea. The median age of patients with diarrhea was 59 years (44 to 64), and 22 (40.7%) were male. Systemic steroid use, intensive care unit admission, septic shock, and acute respiratory distress syndrome were less frequent in the diarrhea group than in the non-diarrhea group. No significant differences were observed in total hospital stay and mortality between groups. On multivariate analysis, age (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.01 to 1.12; p = 0.044), diabetes (OR, 3.00; 95% CI, 1.25 to 20.47; p = 0.042), and dyspnea (OR, 41.19; 95% CI, 6.60 to 823.16; p < 0.001) were independent risk factors for septic shock. On Cox regression analysis, diabetes (hazard ratio [HR], 4.82; 95% CI, 0.89 to 26.03; p = 0.043) and chronic obstructive pulmonary disease (HR, 16.58; 95% CI, 3.10 to 88.70; p = 0.044) were risk factors for mortality. @*Conclusions@#Diarrhea was present in 45.8% of patients and was a common symptom of COVID-19. Although patients with diarrhea showed less severe clinical features, diarrhea was not associated with disease severity or mortality.

Serous Cystadenoma of the Pancreas with Dilatation of Bile and Pancreatic Duct / 대한소화기병학회잡지

No abstract available.

Duodenal Diverticulitis Treated by Repeated Therapeutic Irrigation Using Endoscopy / 대한췌담도학회지

No abstract available.

Serous Cystadenoma of the Pancreas with Dilatation of Bile and Pancreatic Duct / 대한소화기학회지

No abstract available.

Prospective analysis of factors associated with inadequate bowel preparation for colonoscopy in actual clinical practice

BACKGROUND/AIMS: Inadequate bowel preparation can result in prolonged procedure time and increased missed lesion and complication rates. This prospective study aimed to evaluate bowel preparation quality and identify the predictive factors for inadequate bowel preparation in actual clinical practice. METHODS: We included 399 patients who underwent colonoscopy between June 2015 and July 2016. Using the Aronchick bowel preparation scale, we defined a score ≤2 as adequate preparation and a score >2 as inadequate preparation. RESULTS: Mean patient age was 58.38±12.97 years; 60.6% were male. Indications for colonoscopy included screening (69.7%) and surveillance after polyp removal (21.3%). A split-dose regimen was prescribed to 55.4% of patients. The inadequate bowel preparation rate was 28.1%. Overall, the median time between the last bowel preparation agent dose and start of colonoscopy was 5.0 hours (range, 1.5–16.0 hours); that of the adequate group was 5.0 hours (range, 1.5–16.0 hours); and that of the inadequate group was 5 hours (range, 2–23 hours). The mean bowel preparation scale score of the ascending colon (1.94±0.25) was significantly higher than that of other colon segments. On multivariate analysis, elderly age, history of cerebrovascular disease, history of gastrectomy or appendectomy, and total preparation solution uptake < 2 L were the independent predictors of inadequate bowel preparation. CONCLUSIONS: The inadequate bowel preparation rate was 28.1%. Risk factors included elderly age and history of cerebrovascular disease or abdominal surgery. Patients with these risk factors require special care and education.

Large Pancreatolith Formed in the Remnant Cyst after Incomplete Excision of Choledochal Cyst / 대한췌담도학회지

No abstract available.

Aberrant Opening of the Common Bile Duct with Precancerous Change / 대한췌담도학회지

A 43-year-old male was admitted to our hospital via emergency room with epigastric pain for 3 days. Abdominal computed tomography revealed pneumobilia in the biliary tree. Endoscopic retrograde cholangiopancreatography showed an atypical location of ampulla of Vater (AOV) with duodenal deformity. The plastic stent was placed through the fistular opening at the upper mound of AOV for biliary decompression. He was rehospitalized due to aggravation of jaundice two weeks later. The previous stent was changed into the nasobiliary catheter and biopsy was done around the ectopic opening. He underwent Whipple's operation due to the high grade dysplasia on biopsy. This is the report of aberrant opening of the common bile duct (CBD) into the duodenal bulb with precancerous conditions. Therefore, endoscopic biopsy is recommended in patients with mucosal abnormality around the ectopic opening of the CBD.

Histologic discrepancy between endoscopic forceps biopsy and endoscopic mucosal resection specimens of colorectal polyp in actual clinical practice

BACKGROUND/AIMS: We aimed to assess the rate of histologic discrepancy (HD) between endoscopic forceps biopsy (EFB) and totally resected specimens in colorectal polyp and analyze the risk factors of discordant group, especially under-diagnosis (UD) cases before complete removal of colorectal polyp. METHODS: From 2010 to 2015, a total of 290 polyps in 210 patients which had baseline pathology report before endoscopic resection (ER) were analyzed. UD cases were defined as those in which the diagnosis changed to a more advanced histologic feature after ER. RESULTS: A change in the final histology after ER was noted in 137 cases (47.2%), and after excluding 9 insignificant cases, 128 cases were further categorized into over-diagnosed and under-diagnosed group. UD occurred in 86 cases (29.7%) and change from benign to malignancy was noted in 26 cases (8.9%). On univariate analysis, a larger polyp size (>10 mm) was significantly associated with both HD (P 10 mm was the single most significant predictor of both HD (P 10 mm was the most important predictor of both HD and UD. We should be careful in making treatment strategy of colorectal polyp based on histologic report of EFB especially when the size of polyp is >10 mm.

Annular Pancreas in Adult / 대한소화기학회지

No abstract available.

Tuberculous Lymphadenitis Mimicking Gastric Subepithelial Tumor Diagnosed Using Endoscopic Ultrasound-guided Fine-needle Aspiration

A gastric subepithelial tumor (SET) is commonly detected during a diagnostic endoscopic examination. Gastric tuberculosis (TB), in particular, can present as a SET of the gastric wall. A few cases of gastric TB mimicking a SET have recently been reported. Radiological imaging combined with endoscopic biopsy can aid in the early diagnosis of TB without surgical intervention. A 41-year-old man visited our health promotion center for a regular check-up. Esophagogastroduodenoscopy (EGD) revealed a round and smooth, bulging mucosal lesion suggesting a gastric SET in the upper body of the stomach. Endoscopic ultrasound (EUS) demonstrated a hypoechoic lesion measuring 18 mm, with an obscure layer of origin, and EUS-guided fine-needle aspiration was performed. Microscopic examination of the sample showed chronic granulomatous inflammation. Histopathologically, the aspirated sample showed positive Ziehl-Neelsen staining, confirming a diagnosis of tuberculous lymphadenitis. We describe a case of a patient who presented with tuberculous lymphadenitis mimicking a SET of the stomach. The lesion was found on EGD and confirmed using EUS-guided fine-needle aspiration.

Diffuse-Type Caroli Disease with Characteristic Central Dot Sign Complicated by Multiple Intrahepatic and Common Bile Duct Stones

Caroli disease (CD) is a rare congenital malformation of the liver characterized by non-obstructive, segmental, cystic dilatation of the intrahepatic bile ducts (IHDs). The clinical course is usually asymptomatic for the first 5–20 years, and symptoms may seldom occur throughout the patient’s life. Bile stagnation leads to recurrent episodes of cholangitis, stone formation, or liver abscesses, and biliary cirrhosis usually occurs years later. Here we report on a 42-year-old man diagnosed with diffuse-type CD with a characteristic central dot sign, who had multiple intrahepatic and common bile duct (CBD) stones. CBD stones were treated successfully with endoscopic retrograde cholangiopancreatography (ERCP).

Recurrence and Its Impact on the Health-related Quality of Life in Patients with Gastroesophageal Reflux Disease: A Prospective Follow-up Analysis

BACKGROUND/AIMS: Limited data exist on the outcome of gastroesophageal reflux disease (GERD) treatment and its impact on the health-related quality of life (HRQoL) in the Asian population. This study aims to evaluate the treatment outcomes, to investigate the factors associated with recurrence, and to evaluate the impact of the treatment outcome on the HRQoL in a Korean GERD population. METHODS: This was a prospective, multicenter study involving a total of 824 GERD patients. The response to treatment was assessed at week 4 (or week 8 for the patients who did not achieve complete resolution [CR] at week 4). The EQ-5D questionnaire was used at baseline, end of treatment, and first recurrence to assess the HRQoL. To assess GERD symptoms, contact of patients by phone at 1, 6, and 12 months following treatment was carried out. RESULTS: CR was achieved in 65.6% and recurrence was observed in 47.8% following treatment. CR and recurrence rates did not differ by the presence of esophagitis. Multivariate analysis revealed that acid regurgitation (odds ratio 2.249; 95% confidence interval 1.293-3.912; P = 0.004) and both acid regurgitation and heartburn (odds ratio 2.330; 95% confidence interval 1.392-3.901; P = 0.001) were independent risk factors for GERD recurrence. EQ-5D scores were more improved in patients with CR than in those without CR, and worsened more during follow-up in patients with recurrence than in those without recurrence. CONCLUSIONS: We should achieve complete symptom relief and attempt to prevent recurrence in GERD patients to improve their HRQoL.

Predictors of Mortality in Korean Patients with Pyogenic Liver Abscess: A Single Center, Retrospective Study / 대한소화기학회지

BACKGROUND/AIMS: The mortality rate of pyogenic liver abscess (PLA) has decreased dramatically, but it remains a potentially life threatening disease. Most cases are cryptogenic or occur in elderly men with underlying biliary tract disease. Although several studies have addressed the characteristics and etiology of PLA, research on factors affecting PLA-associated mortality is lacking. This study intended to identify the clinical and radiological features, pathogens, complications, and predictors of mortality in Korean PLA patients. METHODS: The medical records of 231 PLA patients diagnosed at Yeungnam University Medical Center between January 2010 and January 2014 were analyzed. A diagnosis of PLA was made based on imaging studies and blood and abscess cultures. The clinical, radiological, and laboratory findings of patients were analyzed. RESULTS: The mean patient age was 64.0±12.9 years and the male to female ratio was 1.5:1. Klebsiella pneumoniae was the predominant organism isolated from hepatic abscesses (69.9%) and blood (74.2%). The most common complication was pleural effusion (35.8%) and most common co-infection was cholangitis (8.2%). The overall mortality rate of PLA was 6.9% (16/231), and was significantly higher in patients with a history of liver abscess (OR 5.970, 95% CI 1.207-29.529; p=0.028), bilirubinemia (>2 mg/dL) (OR 9.541, 95% CI 2.382-38.216; p=0.001), thrombocytopenia (<140×10(3)/µL) (OR 4.396, 95% CI 1.130-17.106; p=0.033), or anemia (<12 g/dL) (OR 13.277, 95% CI 1.476-119.423; p=0.021). CONCLUSIONS: The prognosis of PLA appears to be dependent on underlying pathologies and severity of condition. More aggressive treatment should be considered if a poor prognosis is expected.

Endoscopic Resection of Sporadic Non-ampullary Duodenal Neoplasms: A Single Center Study / 대한소화기학회지

BACKGROUND/AIMS: Sporadic non-ampullary duodenal neoplasms are rare and optimal treatment for these lesions remains undefined. Endoscopic resection of duodenal neoplasms is widely used recently and it is an alternative treatment strategy to surgical excision. This study aimed to evaluate the safety and efficacy of endoscopic resection of duodenal neoplasms and to determine its outcomes. METHODS: Patients who underwent endoscopic resection for non-ampullary duodenal neoplasms between January 2005 and December 2014 were analyzed retrospectively. Data including size, morphology, histology, location and endoscopic procedural technique were reviewed. The main outcome measurements were success rate, complication, recurrence and follow-up assessments. RESULTS: The study included 33 patients with duodenal neoplasms. The mean size of resected lesion was 8.58 mm. The results of histologic examination were as follows: 23 (69.7%) adenomas, 2 (6.1%) adenocarcinoma, 3 (9.1%) Brunner's gland tumor and 3 (9.1%) neuroendocrine tumor. Tubular adenoma wase the most common type (63.6%) of non-ampullary duodenal neoplasms. Eighteen (54.5%) lesions were found in the second portion of the duodenum, and 10 (30.3%) lesions on bulb and 3 (9.1%) lesions on superior duodenal angle. Of the 33 cases, 32 (97.0%) were managed by endoscopic mucosal resection technique during a single session and one case was managed by endoscopic submucosal dissection (ESD). One episode of perforation occurred after ESD. During a median follow-up period of 5.76 months, recurrence was observed in only one case of in a patient with tubular adenoma. CONCLUSIONS: Endoscopic resection of duodenal neoplasm is a safe and effective treatment modality that can replace surgical resection in many cases. Careful endoscopic follow-up is essential to manage recurrence or residual lesions.

Splenic rupture following transcatheter arterial embolization of splenic artery pseudoaneurysm caused by acute pancreatitis

No abstract available.