A Median Arcuate Ligament Syndrome Could Be Re-termed as a Nutcracker Celiac Ganglion Abdominal Pain Syndrome

Background/Aims@#Median arcuate ligament syndrome (MALS) is known as chronic recurrent abdominal pain related to compression of the celiac artery by the median arcuate ligament. We aim to seek the specific mechanism of the pain by evaluating symptoms and radiological characteristics on abdominal CT scans. @*Methods@#We analyzed 35 patients who visited the emergency room for recurrent abdominal pain after cholecystectomy. We classified the characteristics of patients as 4 clinical components and 2 radiological components. We defined the sum of weighted clinical scores and weighted radiological scores as nutcracker ganglion abdominal pain syndrome (NCGAPS) scores. We categorized the patients into 3 groups classified by the degree of NCGAPS scores. The 3 patients with top-3 NCGAPS scores were recommended for CT angiography. @*Results@#When the suspicion was graded by NCGAPS scores, post stenotic dilatation was significantly different among all groups (P < 0.001).The clinical components of pain varied positional or respirational change and continuous pain were significantly different among all the groups (P < 0.01). NCGAPS scores can remarkably differentiate highly suspicious patients in comparison to simply combined scores. Only 1 patient in the highly suspicious group by NCGAPS scores took the CT angiography and was confirmed with NCGAPS. @*Conclusions@#We suggest renaming MALS as NCGAPS, nutcracker celiac ganglion abdominal pain syndrome, to better explain the mechanism of the recurrent abdominal pain. Further studies on the diagnostic cutoff of clinical and radiological scores of NCGAPS are needed not to miss the diagnosis of NCGAPS.

Outcomes of Endoscopic Resection for Early Gastric Cancer in Very Elderly Patients: A Nationwide Population-Based Study

Background/Aims@#Few studies have investigated the long-term outcomes of endoscopic resection for early gastric cancer (EGC) in very elderly patients. The aim of this study was to determine the appropriate treatment strategy and identify the risk factors for mortality in these patients. @*Methods@#Patients with EGC who underwent endoscopic resection from 2006 to 2017 were iden-tified using National Health Insurance Data and divided into three age groups: very elderly (≥85 years), elderly (65 to 84 years), and non-elderly (≤64 years). Their long- and short-term outcomes were compared in the three age groups, and the survival in the groups was compared with that in the control group, matched by age and sex. We also evaluated the risk factors for long- and short-term outcomes. @*Results@#A total of 8,426 patients were included in our study: 118 very elderly, 4,583 elderly, and 3,725 non-elderly. The overall survival and cancer-specific survival rates were significantly lower in the very elderly group than in the elderly and the non-elderly groups. Congestive heart failure was negatively associated with cancer-specific survival. A significantly decreased risk for mortality was observed in all groups (p<0.001). The very elderly group had significantly higher readmission and mortality rates within 3 months of endoscopic resection than the non-elderly and elderly groups. Furthermore, the cerebrovascular disease was associated with mortality within 3 months after endoscopic resection. @*Conclusions@#Endoscopic resection for EGC can be helpful for very elderly patients, and it may play a role in achieving overall survival comparable to that of the control group.

Clinical Outcomes and Adverse Events of Gastric Endoscopic Submucosal Dissection of the Mid to Upper Stomach under General Anesthesia and Monitored Anesthetic Care

Background/Aims@#Endoscopic submucosal dissection (ESD) of gastric tumors in the mid-to-upper stomach is a technically challenging procedure. This study compared the therapeutic outcomes and adverse events of ESD of tumors in the mid-to-upper stomach performed under general anesthesia (GA) or monitored anesthesia care (MAC). @*Methods@#Between 2012 and 2018, 674 patients underwent ESD for gastric tumors in the midbody, high body, fundus, or cardia (100 patients received GA; 574 received MAC). The outcomes of the propensity score (PS)-matched (1:1) patients receiving either GA or MAC were analyzed. @*Results@#The PS matching identified 94 patients who received GA and 94 patients who received MAC. Both groups showed high rates of en bloc resection (GA, 95.7%; MAC, 97.9%; p=0.68) and complete resection (GA, 81.9%; MAC, 84.0%; p=0.14). There were no significant differences between the rates of adverse events (GA, 16.0%; MAC, 8.5%; p=0.18) in the anesthetic groups. Logistic regression analysis indicated that the method of anesthesia did not affect the rates of complete resection or adverse events. @*Conclusions@#ESD of tumors in the mid-to-upper stomach at our high-volume center had good outcomes, regardless of the method of anesthesia. Our results demonstrate no differences between the efficacies and safety of ESD performed under MAC and GA.

Impact of Helicobacter pylori Eradication on the Risk of Incident Nonalcoholic Fatty Liver Disease: A Cohort Study

Background/Aims@#Previous studies have reported an association between Helicobacter pylori (H. pylori) infection and nonalcoholic fatty liver disease (NAFLD). Our study examined whether eradication for H. pylori infection reduces the risk of incident NAFLD. @*Materials and Methods@#This retrospective cohort study examined 3,780 adults who had no NAFLD at baseline but were infected with H. pylori. The study population was followed from January 1995 until January 2020. H. pylori infection was determined by an H. pylori-specific IgG antibody test. Fatty liver was diagnosed by ultrasound. @*Results@#During a median follow-up of 7.9 years, 1,294 participants developed NAFLD. In a multivariable model adjusted for age, sex, BMI, smoking status, alcohol intake, and metabolic variables, the uneradicated (for H. pylori) group exhibited a higher risk of incident NAFLD than the eradicated group (hazard ratio [HR], 1.36; 95% CI, 1.18~1.56). The multivariable analysis also demonstrated that higher BMI, current smoking and several metabolic abnormalities were significant risk factors for NAFLD. Subgroup analyses revealed that persistent H. pylori infection correlated with an increased risk of NAFLD. H. pylori eradication was associated with a decreased risk of NAFLD development. @*Conclusions@#H. pylori infection may have a pathophysiological role in NAFLD development. Hence, successful eradication of H. pylori decreases the risk of incident NAFLD.

Long-term Outcomes of Additional Endoscopic Treatments for Patients with Positive Lateral Margins after Endoscopic Submucosal Dissection for Early Gastric Cancer

Background/Aims@#It is uncertain whether additional endoscopic treatment may be chosen over surgery in patients with positive lateral margins (pLMs) as the only non-curative factor after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). We aimed to compare the long-term outcomes of additional endoscopic treatments in such patients with those of surgery and elucidate the clinicopathological factors that could influence the treatment selection. @*Methods@#A total of 99 patients with 101 EGC lesions undergoing additional treatment after noncurative ESD with pLMs as the only non-curative factor were analyzed. Among them, 25 (27 lesions) underwent ESD, 29 (29 lesions) underwent argon plasma coagulation (APC), and 45 (45 lesions) underwent surgery. Clinicopathological characteristics and long-term outcomes were compared. @*Results@#Residual tumor was found in 73.6% of cases. The presence of multiple pLMs was associated with higher risk of residual tumor (p=0.046). During a median follow-up of 58.9 months, recurrent or residual lesions after additional ESD and APC were found in 4% (1/25) and 6.8% (2/29) of patients, respectively. However, all were completely cured with surgery or repeated ESD. There were no extragastric recurrences after additional endoscopic treatment. Lymph node metastasis was identified after additional surgery in one (2.2%) patient with an EGC showing histological heterogeneity. @*Conclusions@#Given the favorable long-term outcomes, additional ESD or APC may be an acceptable choice for patients with pLMs as the only non-curative factor after ESD for EGC. However, clincopathological characteristics such as multiple pLMs and histological heterogeneity should be considered in the treatment selection.

Risk-Scoring System for Prediction of Non-Curative Endoscopic Submucosal Dissection Requiring Additional Gastrectomy in Patients with Early Gastric Cancer

Purpose@#When patients with early gastric cancer (EGC) undergo non-curative endoscopic submucosal dissection requiring gastrectomy (NC-ESD-RG), additional medical resources and expenses are required for surgery. To reduce this burden, predictive model for NC-ESDRG is required. @*Materials and Methods@#Data from 2,997 patients undergoing ESD for 3,127 forceps biopsyproven differentiated-type EGCs (2,345 and 782 in training and validation sets, respectively) were reviewed. Using the training set, the logistic stepwise regression analysis determined the independent predictors of NC-ESD-RG (NC-ESD other than cases with lateral resection margin involvement or piecemeal resection as the only non-curative factor). Using these predictors, a risk-scoring system for predicting NC-ESD-RG was developed. Performance of the predictive model was examined internally with the validation set. @*Results@#Rate of NC-ESD-RG was 17.3%. Independent pre-ESD predictors for NC-ESD-RG included moderately differentiated or papillary EGC, large tumor size, proximal tumor location, lesion at greater curvature, elevated or depressed morphology, and presence of ulcers. A risk-score was assigned to each predictor of NC-ESD-RG. The area under the receiver operating characteristic curve for predicting NC-ESD-RG was 0.672 in both training and validation sets. A risk-score of 5 points was the optimal cut-off value for predicting NCESD-RG, and the overall accuracy was 72.7%. As the total risk score increased, the predicted risk for NC-ESD-RG increased from 3.8% to 72.6%. @*Conclusions@#We developed and validated a risk-scoring system for predicting NC-ESD-RG based on pre-ESD variables. Our risk-scoring system can facilitate informed consent and decision-making for preoperative treatment selection between ESD and surgery in patients with EGC.

Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study

Background/Aims@#Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD. @*Methods@#In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed. @*Results@#The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events. @*Conclusion@#In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.

Endoscopic Prediction for Acid Reflux in Patients without Hiatus Hernia / 대한소화기학회지

Background/Aims@#A diagnosis of gastroesophageal reflux disease is challenging in patients who have reflux symptoms but do not respond to proton pump inhibitors nor have reflux esophagitis and hiatal hernia (HH) on endoscopy. This study examined the predictive role of the endoscopic findings, including the flap valve grade for pathologic acid exposure (PAE) to establish an endoscopic prediction model in patients with neither reflux esophagitis nor HH. @*Methods@#Five hundred seventy-eight patients who underwent upper endoscopy and 24 hours pH monitoring for reflux esophageal symptoms without evidence of reflux esophagitis and HH were analyzed. The gastroesophageal flap valve (GEFV), esophageal metaplasia, and chronic atrophic gastritis were assessed. The association between the endoscopic parameters and PAE was evaluated. @*Results@#Four hundred ninety-four patients were enrolled. The most common complaint was chest discomfort (42.3%) followed by globus (31.8%), dysphagia (7.9%), and heartburn (7.7%). PAE was present in 43 patients (8.7%). Multivariable analysis revealed PAE to be associated with the GEFV grade (p<0.001) and inversely associated with the chronic atrophic gastritis grade (p=0.005). Using these features, a predictive model was established and showed an area under the receiver operating characteristic curve of 0.705 (95% CI 0.619-0.790). The cutoff value of 12.0 had a sensitivity and specificity of 44.0% and 84.0%, respectively. @*Conclusions@#A loosened GEFV is associated with a risk of PAE in patients with neither reflux esophagitis nor HH, while atrophic gastritis is preventive. On the other hand, the endoscopic predictive model revealed a low sensitivity for detecting PAE. Thus, reflux testing needs to be performed further when gastroesophageal reflux disease is suspected, even without endoscopic evidence.

Proton pump inhibitor use is associated with hip fracture development: a nationwide populationbased cohort study

Background/Aims@#Effect of proton pump inhibitor (PPI) use on the risk of hipfracture is controversial. This study aimed to clarify the association between PPIuse and hip fracture risk using a large cohort. @*Methods@#This study recruited participants from the nationwide cohort (n =1,025,340). After exclusion of participants who had hip fractures or were aged less than 40 years during the baseline period (2002 to 2004), 371,806 participants were followed to 2013. Participants prescribed PPIs for more than 90 days during baseline period were defined as users. Fracture cases were defined when participants were hospitalized with claims of a hip fracture. @*Results@#During 4,159,343 person-years of follow-up, fractures developed more oftenin PPI users than in nonusers (relative risk [RR], 1.787; 95% confidence interval [CI], 1.260 to 2.534; p = 0.002). The results persisted after adjusting for age, sex, andmany drugs relevant to osteoporosis or influential in bone health. Furthermore,fracture risk associated with PPI use increased with duration of use ( p trend 180-day users. The positive association between PPI use and fracture was also confirmed in a subgroup with health screening data where further adjustment for body mass index, smoking status, alcohol consumption, and physical activity was available (adjusted RR, 2.025; 95% CI, 1.151 to 3.564, p = 0.014). Conclusions: PPI use is associated with hip fracture development.

Impact of Sarcopenia on the Risk of Erosive Esophagitis / 대한소화기학회지

BACKGROUND/AIMS: An association between obesity and erosive esophagitis has been reported, but the effects of sarcopenia and obesity on erosive esophagitis are unknown. This study examined the relationship between obesity, sarcopenia, sarcopenic obesity, and erosive esophagitis in a large population of asymptomatic men and women.METHODS: This study analyzed 32,762 subjects who underwent a comprehensive health check-up, which included upper gastrointestinal endoscopy, from August 2006 to December 2011 by a cross-sectional study. Sarcopenia was defined as a decrease in the appendicular skeletal muscle mass (ASM)/body weight value of two SD or more below the normal means for a younger reference group.RESULTS: The study was carried out on four groups according to obesity and sarcopenic status: normal, obesity, sarcopenic, and sarcopenic obese group. In a multivariable model, the risk of erosive esophagitis was higher in the obese (adjusted OR [aOR] 1.35, 95% CI 1.22–1.49), sarcopenic (aOR 2.12, 95% CI 1.40–3.19), and sarcopenic obese groups (aOR 1.54, 95% CI 1.27–1.87) than in the normal group. The risk of erosive esophagitis was higher in the sarcopenic and sarcopenic obese groups than the obese group; the ORs were 1.63 (95% CI 1.08–2.47) and 1.22 (95% CI 1.01–1.46), respectively. In dose-response analysis, increasing sarcopenia severity showed a positive and graded relationship with the overall, Los Angeles (LA)-B or higher grade, and LA-C erosive esophagitis.CONCLUSIONS: This study suggests that sarcopenia is strongly and progressively associated with erosive esophagitis.

Lack of Association between Helicobacter pylori Infection and Various Markers of Systemic Inflammation in Asymptomatic Adults / 대한소화기학회지

BACKGROUND/AIMS: Helicobacter pylori (H. pylori) infection has been known to cause various extra-gastric diseases, which may be mediated by an increase in systemic inflammation. Thus, we examined the association between H. pylori infection and various markers of systemic inflammation in a large sample of asymptomatic adults. METHODS: Cross-sectional data were obtained from 17,028 adults who completed routine health check-ups. H. pylori infection status was determined using a serum immunoglobulin G test, and systemic inflammation was assessed using the C-reactive protein (CRP) levels, neutrophil/lymphocyte ratio (NLR), and platelet/lymphocyte ratio (PLR). RESULTS: Multiple linear regression model-adjusted for potential confounders-revealed that H. pylori infection was not associated with CRP levels (coefficient: −0.012, 95% confidence interval [CI]: −0.037, 0.012, p=0.319), NLR (coefficient: 0.055, 95% CI: −0.027, 0.138, p=0.192), or PLR (coefficient: 1.798, 95% CI: −1.979, 5.574, p=0.351). In a multivariable logistic regression model, H. pylori infection was not associated with the risk of CRP levels being elevated to ≥0.1 mg/dL (odds ratio: 0.96, 95% CI: 0.81, 1.08) or ≥0.3 mg/dL (odds ratio: 1.02, 95% CI: 0.84, 1.19). In the multivariable model, CRP levels elevated to ≥0.1 mg/dL were significantly associated with body mass index, current smoking status, hypertension, and diabetes mellitus. Regular exercise and high-density lipoprotein cholesterol were factors that minimized the elevation of CRP levels. CONCLUSIONS: Chronic infection with H. pylori was not associated with various inflammatory markers. Further investigation is needed to clarify the interaction between H. pylori infection, systemic inflammation, and extra-gastric disease.

Associations between Atopic Dermatitis and Risk of Gastric Cancer: A Nationwide Population-based Study / 대한소화기학회지

BACKGROUND/AIMS: Epidemiologic and clinical data indicate that allergies may be associated with reduced risks for several cancers; however, to date, only a few studies have examined the associations between allergies and gastric cancer. This study aimed to examine the associations between allergies and gastric cancer using a large population-based dataset. METHODS: This cross-sectional study obtained data from the Korea National Health and Nutrition Examination Survey between 2010 and 2014, involving a total of 24,089 participants. The associations between allergies and gastric cancer were analyzed using univariable and multivariable logistic regression analyses with complex sampling, while adjusting for confounding factors that included age, sex, body mass index, smoking status, alcohol intake, and level of education. RESULTS: Multivariable logistic regression analyses that were adjusted for the potential confounders determined that a history of allergic diseases tended to be associated with reduced risk of gastric cancer; however, this relationship was not statistically significant (any allergy: odds ratio [OR], 0.62; 95% confidence interval [CI], 0.34-1.12; atopic dermatitis: OR, 0.34; 95% CI, 0.50-1.72; allergic rhinitis: OR, 0.71; 95% CI, 0.34-1.46; asthma: OR, 0.44; 95% CI, 0.15-1.29). Multivariable analysis showed that a history of atopic dermatitis was associated with reduced risk of gastric cancer in men (OR, 0.16; 95% CI, 0.03-0.75). CONCLUSIONS: This findings of this study suggest that individuals with allergies tend to have a reduced risk of gastric cancer, without a statistically significant association. Furthermore, atopic dermatitis was associated with reduced risk of gastric cancer, particularly in men.

Increased Tone of the Human Colon Muscle by Bisacodyl In Vitro

BACKGROUND/AIMS: Although bisacodyl is a widely administered laxative, its underlying mechanism of action remains generally unknown. This study focuses on investigating the effects of bisacodyl on the human colon muscle contraction, and elucidating its mechanism of action. METHODS: Sigmoid colon muscle strips (20 longitudinal and 18 circular muscles) were obtained from 20 subjects who underwent colectomy for colon cancer. Isometric force measurements were calculated in response to electrical field stimulation (EFS, 0.3 milliseconds in trains of 10 Hz for 20 seconds, 150 V). Peak and nadir (tone) during and after EFS, were measured in a controlled state, and after sequential addition of bisacodyl (1 μM), atropine (1 μM), N-nitro-L-arginine (L-NNA, 100 μM), MRS2500 (1 μM), and tetrodotoxin (TTX, 1 μM) to the organ bath. RESULTS: Transient phasic contractions were observed during EFS, and after cessation of EFS. In the longitudinal muscles, nadir during EFS, and tone after EFS, significantly increased after addition of bisacodyl, and persisted after sequential addition of atropine, L-NNA, MRS2500, and TTX, indicating a direct action of bisacodyl on the smooth muscle. In the second experiment, pretreatment of TTX abolished EFS-induced phasic contractions. Although no phasic contraction was produced after perfusion of bisacodyl, tone was increased, thereby supporting evidence of a direct mechanism of action of bisacodyl on the colon smooth muscle. CONCLUSIONS: Bisacodyl increases the tone of longitudinal muscle in the human sigmoid colon through a direct action on the smooth muscle. Further study is warranted to investigate the neural mechanism of action of bisacodyl.

Comparative Study of Esophageal Self-expandable Metallic Stent Insertion and Gastrostomy Feeding for Dysphagia Caused by Lung Cancer / 대한소화기학회지

BACKGROUND/AIMS: Dysphagia is encountered in a large proportion of patients with lung cancer and is associated with malnutrition and a poor quality of life. This study compared the clinical outcomes of self-expandable metallic stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding for patients with lung cancer and dysphagia. METHODS: A total of 261 patients with lung cancer, who underwent either SEMS insertion (stent group) or PG (gastrostomy group) as an initial treatment procedure for dysphagia between July 1997 and July 2015 at the Samsung Medical Center, were reviewed retrospectively, and 84 patients with esophageal obstruction were identified. The clinical outcomes, including the overall survival, additional intervention, complications, and post-procedural nutritional status in the two groups, were compared. RESULTS: Among the 84 patients finally analyzed, 68 patients received SEMS insertion and 16 had PG. The stent group had less cervical obstruction and more mid-esophageal obstruction than the gastrostomy group. The Kaplan-Meier curves revealed similar overall survival in the two groups. Multivariate analysis showed that the two modalities had similar survival rates (PG compared with SEMS insertion, hazard ratio 0.682, p=0.219). Fifteen patients (22.1%) in the stent group received additional intervention, whereas there was no case in the gastrostomy group (p=0.063). The decrease in the serum albumin level after the procedure was lower in the gastrostomy group than in the stent group (-0.20±0.54 g/dL vs. -0.65±0.57 g/dL, p=0.013) CONCLUSIONS: SEMS insertion and PG feeding for relieving dysphagia by lung cancer had a comparable survival outcome. On the other hand, PG was associated with a better nutritional status.

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.

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)

Lactate Parameters Predict Clinical Outcomes in Patients with Nonvariceal Upper Gastrointestinal Bleeding

The predictive role of lactate in patients with nonvariceal upper gastrointestinal bleeding (NVUGIB) has been suggested. This study evaluated several lactate parameters in terms of predicting outcomes of bleeding patients and sought to establish a new scoring model by combining lactate parameters and the AIMS65 score. A total of 114 patients with NVUGIB who underwent serum lactate level testing at least twice and endoscopic hemostasis within 24 hours after admission were retrospectively analyzed. The associations between five lactate parameters and clinical outcomes were evaluated and the predictive power of lactate parameter combined AIMS65s (L-AIMS65s) and AIMS56 scoring was compared. The most common cause of bleeding was gastric ulcer (48.2%). Lactate clearance rate (LCR) was associated with 30-day rebleeding (odds ratio [OR], 0.931; 95% confidence interval [CI], 0.872–0.994; P = 0.033). Initial lactate (OR, 1.313; 95% CI, 1.050–1.643; P = 0.017), maximal lactate (OR, 1.277; 95% CI, 1.037–1.573; P = 0.021), and average lactate (OR, 1.535; 95% CI, 1.137–2.072; P = 0.005) levels were associated with 30-day mortality. Initial lactate (OR, 1.213; 95% CI, 1.027–1.432; P = 0.023), maximal lactate (OR, 1.271; 95% CI, 1.074–1.504; P = 0.005), and average lactate (OR, 1.501; 95% CI, 1.150–1.959; P = 0.003) levels were associated with admission over 7 days. Although L-AIMS65s showed the highest area under the curve for prediction of each outcome, differences between L-AIMS65s and AIMS65 did not reach statistical significance. In conclusion, lactate parameters have a prognostic role in patients with NVUGIB. However, they do not increase the predictive power of AIMS65 when combined.

Effective and Safe Use of Neostigmine in Treatment of Acute Kidney Injury Associated with Colonic Pseudo-obstruction after Cardiac Surgery / 대한소화기학회지

Neostigmine can successfully decompress patients with acute colonic pseudo-obstruction (ACPO) who are unresponsive to conservative therapy. However, neostigmine is contraindicated in renal failure, so it is underused in ACPO patients with renal failure who would be otherwise appropriate candidates. We described the first successfully treated case of acute kidney injury (AKI) with neostigmine in a patient with ACPO. A 72-year-old man who underwent a coronary artery bypass graft surgery 11 days prior presented to the emergency room with abdominal distension, peripheral edema, and dyspnea on exertion. Plain abdominal radiographs and abdomen computed tomography scan showed diffuse colonic dilatation without obstruction. Serum creatinine level was increased five-fold over baseline. We diagnosed the patient as ACPO with AKI. With conservative treatment, renal function failed to improve because the ACPO was not corrected. Administration of neostigmine rapidly resolved ACPO and renal function, avoiding more invasive procedures such as colonoscopic decompression and hemodialysis. Neostigmine appears to be an effective and safe treatment option for ACPO patients with renal failure. Prospective large-scale studies should be carried out to determine the safety and efficacy of neostigmine in ACPO patients with renal failure.

Can Anorectal Manometry Findings Predict Subsequent Late Gastrointestinal Radiation Toxicity in Prostate Cancer Patients? / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: The purpose of this study is to investigate the influence of radiotherapy (RT) on anorectal function and radiation-induced toxicity in patients with prostate cancer. MATERIALS AND METHODS: Fifty-four patients who were treated with RT for prostate cancer (T1c-4N0-1M0) were evaluated. To assess the changes in anorectal function, two consecutive anorectal manometry readings were performed in patients, before and after 4-6 months of RT. Late gastrointestinal (GI) toxicity was defined as symptoms occurring more than 6 months after RT. The median radiation dose was 70.0 Gy (range, 66.0 to 74.0 Gy). Whole pelvis field RT was performed in 16 patients (29.6%). Grade of late radiation toxicity was defined in accordance to the severity of symptoms (Gulliford's scoring system). RESULTS: The median follow-up period was 60 months. Resting anal pressure (p=0.001), squeeze pressure (p or = 2) late toxicities. Elevated resting and squeeze external anal sphincter pressure prior to RT and large urge to defecate volumes after RT were associated with the occurrence of late GI toxicities. CONCLUSION: RT caused symptomatic anorectal dysfunction and resulted in a weakened anal sphincter. Increased urge to defecate volumes after RT were related to late GI toxicities. Elevated resting and squeeze anal sphincter pressure prior to RT rodcan be used to identify patients with an increased risk of late GI toxicities.ConclusionRT caused symptomatic anorectal dysfunction. An increased anal pressure prior to RT and urge to defecate volume after RT was related to an occurrence of late GI toxicities. Application of ARM for screening patients who have an elevated ASP prior to RT could be helpful in identifying patients with an increased risk of late GI toxicities.

Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study

BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. METHODS: In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.