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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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Background/Aims@#Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. @*Materials and Methods@#We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. @*Results@#The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. @*Conclusions@#Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.
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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.
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Background/Aims@#To date, studies on various noninvasive techniques have been suggested to evaluate the degree of liver fibrosis. We aimed to investigate the diagnostic performance of se-rum asialo α1-acid glycoprotein (AsAGP) in the diagnosis of liver cirrhosis compared with chronic hepatitis for clinically useful result. @*Methods@#We conducted a case-control study of 96 patients with chronic liver disease. Chronic hepatitis was defined as the presence of chronic liver disease on ultrasonography, with a liver stiffness of less than 5.0 kPa as shown on magnetic resonance elastography (MRE). Liver cirrho-sis was defined as liver stiffness of more than 5.0 kPa on MRE. The serum AsAGP concentration was compared between the two groups. @*Results@#Serum AsAGP levels were significantly higher in patients with cirrhosis than in those with chronic hepatitis (1.83 μg/mL vs 1.42 μg/mL, p<0.001). Additionally, when comparing pa-tients in each cirrhotic group (Child-Pugh grades A, B, and C) to those with chronic hepatitis, AsAGP levels were significantly higher in all the cirrhotic groups (p<0.05, p<0.01, p<0.001, respectively). The sensitivity and specificity of AsAGP for detecting cirrhosis were 79.2% and 64.6%, respectively, and the area under the curve value was 0.733. The best diagnostic cutoff to predict cirrhosis was 1.4 μg/mL. AsAGP and bilirubin were found to be independent risk factors for the prediction of cirrhosis in the logistic regression analysis. @*Conclusions@#Serum AsAGP showed an acceptable diagnostic performance in predicting liver cirrhosis.
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Background/Aims@#Subepithelial tumors (SETs) are small, mostly asymptomatic lesions with normal overlying mucosa, usually identified incidentally on endoscopy. The aim of this study was to evaluate the pathologic diagnosis of SETs, and to assess the diagnostic yield and impact of endoscopic submucosal dissection (ESD) biopsy on the management of patients with SETs. @*Materials and Methods@#We included 52 subepithelial lesions in this study during the study period. Inclusion criteria included size of the SET >2 cm, and a gastrointestinal stromal tumor (GIST) that cannot be excluded using EUS. We performed an endoscopic biopsy of each SET using the ESD technique. @*Results@#The mean diameter of the lesions was 24.15±6.0 mm. The diagnostic yield of this method was 96.15%. Among the 52 participants, 45 were located in the stomach, four in the esophagus, and three in the duodenum. The pathologic diagnoses included: 17 leiomyomas, 13 GISTs, 11 ectopic pancreases, two carcinomas, two inflammatory fibroid polyps, two Brunner’s gland hyperplasia, two lipomas, one glomus tumor, and two remained undiagnosed. The mean duration of the procedure was 13.44±2.41 minutes. Three complications were associated with the procedure. @*Conclusions@#Deep biopsy via ESD is useful in determining the histopathologic nature of SETs. This method minimizes the need for unnecessary surgery in benign SETs.
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Background/Aims@#The purpose of this study was to investigate the risk factors and long-term clinical outcomes of non-curative resection (NCR) in a large-scale patient population. @*Methods@#We retrospectively analyzed the clinical data of 3,094 patients who underwent endoscopic submucosal dissection (ESD) of early gastric cancer from March 2005 to March 2018 at 13 institutions in Korea. We analyzed the risk factors for NCR and the survival between patients with curative resection and those with NCR with no additional treatment. @*Results@#The NCR rate was 21.4% (661/3,094). In multivariate regression analysis, the risk factors affecting NCR with ESD were old age, undifferentiated tumor, tumor location in the upper body, tumor size ≥2 cm, and presence of an ulcer. In Cox proportional hazard regression analysis, tumor size ≥2 cm, submucosal invasion, positive horizontal margin, and lymphovascular invasion were risk factors for local recurrence. In Kaplan-Meier analysis, there was no statistically significant difference in the overall survival between the two groups (log-rank p=0.788). However, disease-specific survival was significantly lower in the NCR group (log-rank p=0.038). @*Conclusions@#Clinicians should be aware of the risk factors for NCR and local recurrence after ESD for early gastric cancer, and should consider providing additional treatment after NCR.
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BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.
Subject(s)
Humans , Bismuth , Endoscopy , Esophagus , Gastroesophageal Reflux , Heartburn , Omeprazole , Pilot Projects , Proton Pump Inhibitors , Ranitidine , SucralfateABSTRACT
BACKGROUND/AIMS: The adoption of colonoscopy as a primary colorectal cancer (CRC) screening technique has been argued for in Korea, without evidence of patient preferences. This study aimed to investigate patients’ preferences for the primary CRC screening test for the National Cancer Screening Program (NCSP). METHODS: Between June and August 2016, 414 individuals aged ≥50 years who participated in the NCSP were prospectively invited to complete a questionnaire regarding their preferences for the primary CRC screening test and the reasons for their selection. RESULTS: Among the 396 respondents who completed the questionnaire, 124 individuals (31.3%) preferred the fecal immunochemical test (FIT), whereas 272 individuals (68.7%) preferred colonoscopy. Elderly participants preferred the FIT (p < 0.001), whereas participants with a higher education level (p=0.030), a higher income level (p=0.009), or individuals with a family member (p=0.028) or acquaintance (p=0.013) with a history of CRC preferred colonoscopy. Only 12.9% of participants had a bad experience with a previous FIT; however, 39.3% of participants had a bad experience with a previous colonoscopy. CONCLUSIONS: Colonoscopy was preferred to FIT in a 2.2:1 ratio as the primary CRC screening test for the NCSP. Patients’ preference for colonoscopy should be considered for the NCSP in Korea.
Subject(s)
Aged , Humans , Colonoscopy , Colorectal Neoplasms , Early Detection of Cancer , Education , Korea , Mass Screening , Patient Preference , Prospective Studies , Surveys and QuestionnairesABSTRACT
BACKGROUND/AIMS: Post-operative ileus (POI) is a common complication of abdominal surgery. DA-9701, an extract of Pharbitis Semen and Corydalis Tuber, is a new prokinetic agent that also alleviates visceral pain. The aim of this study was to investigate whether DA-9701 can ameliorate POI in rats. METHODS: A total of 32 rats were divided into 4 groups: no surgery/no medication (NSNM), no surgery/medication (NSM), surgery/no medication (SNM), and surgery/medication (SM). Gastrointestinal transit (GIT), which is assessed by migration of charcoal, and cumulative stool weight were measured at 24 hours after surgery. RESULTS: GIT was significantly more delayed in the SNM group than in the other groups (SNM vs NSNM, P < 0.001; SNM vs NSM, P < 0.001; SNM vs SM, P = 0.005). Cumulative stool weight in that group was also lower than in the no surgery groups (SNM vs NSNM, P = 0.007; SNM vs NSM, P = 0.033), and there was no significant difference between the SM group and the no surgery groups (SM vs NSM, P = 0.703; SM vs NSNM, P = 0.347). CONCLUSION: DA-9701 can ameliorate POI by reducing delayed GIT and improving defecation in a rat model of POI.
Subject(s)
Animals , Rats , Charcoal , Corydalis , Defecation , Gastrointestinal Transit , Ghrelin , Ileus , Models, Animal , Semen , Visceral PainABSTRACT
BACKGROUND/AIMS: DA-6034 has anti-inflammatory activities and exhibits cytoprotective effects in acute gastric injury models. However, explanations for the protective effects of DA-6034 on intestinal permeability are limited. This study sought to investigate the effect of DA-6034 on intestinal permeability in an indomethacin-induced small intestinal injury model and its protective effect against small intestinal injury. METHODS: Rats in the treatment group received DA-6034 from days 0 to 2 and indomethacin from days 1 to 2. Rats in the control group received indomethacin from days 1 to 2. On the fourth day, the small intestines were examined to compare the severity of inflammation. Intestinal permeability was evaluated by using fluorescein isothiocyanate-labeled dextran. Western blotting was performed to confirm the association between DA-6034 and the extracellular signal-regulated kinase (ERK) pathway. RESULTS: The inflammation scores in the treatment group were lower than those in the control group, but the difference was statistically insignificant. Hemorrhagic lesions in the treatment group were broader than those in the control group, but the difference was statistically insignificant. Intestinal permeability was lower in the treatment group than in the control group. DA-6034 enhanced extracellular signal-regulated kinase expression, and intestinal permeability was negatively correlated with ERK expression. CONCLUSIONS: DA-6034 may decrease intestinal permeability in an indomethacin-induced intestinal injury model via the ERK pathway.
Subject(s)
Animals , Rats , Blotting, Western , Dextrans , Fluorescein , Indomethacin , Inflammation , Intestine, Small , MAP Kinase Signaling System , Permeability , PhosphotransferasesABSTRACT
Myeloid sarcoma (MS) is an extramedullary involvement of immature myeloid proliferation. An isolated MS is defined as a myeloblastic tumor when it arises without any concomitant circulating disease. A diagnosis of MS is established using pathologic features including infiltration of myeloblasts and strong myeloperoxidase expression with negative cytokeratin immunohistochemical staining. We report a rare case of colonic MS without any peripheral blood abnormality. If the affected patient were left untreated, the MS could evolve into acute myeloid leukemia (AML) within one year. Several studies recommend the same regimens of chemotherapy as used for circulating AML to treat isolated MS. We focused on the diagnosis of MS in this study. The correct diagnosis of MS is important for adequate treatment. In conclusion, MS should be considered in the differential diagnosis of intestinal tumor.
Subject(s)
Humans , Colon , Colonic Neoplasms , Diagnosis , Diagnosis, Differential , Drug Therapy , Granulocyte Precursor Cells , Intestines , Keratins , Leukemia, Myeloid, Acute , Peroxidase , Sarcoma, MyeloidABSTRACT
BACKGROUND/AIMS: The incidental finding of gastrointestinal subepithelial tumors (SETs) is increasing with national cancer screening endoscopy. In a Swedish population, screening endoscopy found a prevalence of SETs of 0.36%. However, the prevalence of gastric SETs in Korean patients has not been described. Therefore, this study evaluated the prevalence of SETs of the stomach in a Korean patient population. METHODS: We reviewed endoscopic reports of 11,712 subjects who underwent screening esophagogastroduodenoscopy (EGD) at Hanyang University Hospital between July 2012 and June 2013. RESULTS: Among 11,712 patients, 194 (1.7%) had SET of the stomach. Of these, 71 (prevalence, 0.6%) were male and 123 (prevalence, 1.1%) were female. When grouped by age, the prevalence of SET was as follows: 1.0% for patients in their twenties, 6.2% for those in their thirties, 19.1% for those in their forties, 33.0% for those in their fifties, 30.4% for those in their sixties, and 10.3% for those over 70 years of age. CONCLUSIONS: The overall prevalence of gastric SET among healthy examinees was 1.7%. The prevalence of gastric SET increased with age and was higher in female.
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Age Factors , Asian People , Early Detection of Cancer , Endoscopy, Digestive System , Neoplasms, Glandular and Epithelial/diagnosis , Prevalence , Republic of Korea/epidemiology , Retrospective Studies , Risk Factors , Sex Factors , Stomach Neoplasms/diagnosisABSTRACT
Tumor lysis syndrome is rare in hepatocellular carcinoma (HCC), but it has been reported more frequently recently in response to treatments such as transcatheter arterial chemoembolization (TACE), radiofrequency thermal ablation (RFTA), and sorafenib. Tumor lysis syndrome induced by low-dose steroid appears to be very unusual in HCC. We report a patient with hepatitis-C-related liver cirrhosis and HCC in whom tumor lysis syndrome occurred due to low-dose steroid (10 mg of prednisolone). The patient was a 90-year-old male who presented at the emergency room of our hospital with general weakness and poor oral intake. He had started to take prednisolone to treat adrenal insufficiency 2 days previously. Laboratory results revealed hyperuricemia, hyperphosphatemia, and increased creatinine. These abnormalities fulfilled the criteria in the Cairo-Bishop definition of tumor lysis syndrome. Although the patient received adequate hydration, severe metabolic acidosis and acute kidney injury progressed unabated. He finally developed multiple organ failure, and died 3 days after admission. This was a case of tumor lysis syndrome caused by administration of low-dose steroid in a patient with HCC.
Subject(s)
Aged, 80 and over , Humans , Male , Acute Kidney Injury/pathology , Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/pathology , Chemoembolization, Therapeutic , Creatinine/blood , Liver Neoplasms/pathology , Niacinamide/analogs & derivatives , Phenylurea Compounds/therapeutic use , Steroids/adverse effects , Tomography, X-Ray Computed , Tumor Lysis Syndrome/diagnosisABSTRACT
Duodenal diverticulitis is a rare cause of upper abdominal pain and is usually not considered when evaluating patients with acute upper abdominal pain. Furthermore, the duodenum is located near the pancreas and bile duct, and duodenal diverticulitis can be misdiagnosed as acute pancreatitis, cholangitis, cholecystitis, or other pancreatobiliary disorders such as pancreatic cystic neoplasms. Recently, we experienced a rare case of duodenal diverticulitis in the 3rd portion of the duodenum. The patient presented with deep seated upper abdominal pain aggravated by supine posture and relieved by sitting up. The patient was initially diagnosed with acute pancreatitis. However, serum levels of pancreatic enzymes were normal and abdominal CT scan revealed diverticulitis in the 3rd portion of the duodenum. The patient was successfully managed conservatively. Delayed diagnosis of duodenal diverticulitis can result in substantial morbidity and mortality if duodenal perforation occurs and should be considered as a possible cause of upper abdominal pain.
Subject(s)
Humans , Abdominal Pain , Bile Ducts , Cholangitis , Cholecystitis , Delayed Diagnosis , Diverticulitis , Duodenum , Mortality , Pancreas , Pancreatic Cyst , Pancreatitis , Posture , Tomography, X-Ray ComputedABSTRACT
BACKGROUND/AIMS: Because of the similarities in the clinical presentations of Crohn's disease (CD) and intestinal tuberculosis (ITB), differential diagnosis is critical. Mesenteric adipose tissue hypertrophy and creeping fat are characteristic features of CD. The purpose of this study was to assess the usefulness of visceral fat for the differential diagnosis of CD and ITB. METHODS: We conducted a retrospective review of 50 patients with findings of CD or ITB between January 2005 and July 2008. Abdominal computed tomography (CT) was performed on all subjects during their first evaluation. The abdominal fat area was assessed using quantitative abdominal CT. RESULTS: The ratio of visceral fat to total fat (VF/TF) was significantly higher in male CD patients than in male ITB patients. The ratio of visceral fat to subcutaneous fat (VF/SF) was also higher in CD patients than in patients with ITB. For a VF/TF cut-off value of 0.46, the sensitivity and specificity for the diagnosis of CD were 42.1% and 93.3% respectively, with positive and negative predictive values of 88.9% and 56.0%, respectively. CONCLUSION: Measurement of the abdominal fat area using CT can be clinically useful for the differential diagnosis of CD and ITB.
Subject(s)
Humans , Male , Abdominal Fat , Adipose Tissue , Crohn Disease , Diagnosis , Diagnosis, Differential , Hypertrophy , Intra-Abdominal Fat , Retrospective Studies , Sensitivity and Specificity , Subcutaneous Fat , Tomography, X-Ray Computed , TuberculosisABSTRACT
BACKGROUND/AIMS: DA-9701, a standardized extract of Pharbitis Semen and Corydalis Tuber, is a new prokinetic agent that exhibits an analgesic effect on the abdomen. We investigated whether DA-9701 affects visceral pain induced by colorectal distension (CRD) in rats. METHODS: A total of 21 rats were divided into three groups: group A (no CRD+no drug), group B (CRD+no drug), and group C (CRD+DA-9701). Expression of pain-related factors, substance P (SP), c-fos, and phosphorylated extracellular signal-regulated kinase (p-ERK) in the dorsal root ganglion (DRG) and spinal cord was determined by immunohistochemical staining and Western blotting. RESULTS: The proportions of neurons in the DRG and spinal cord expressing SP, c-fos, and p-ERK were higher in group B than in group A. In the group C, the proportion of neurons in the DRG and spinal cord expressing p-ERK was lower than that in group B. Western blot results for p-ERK in the spinal cord indicated a higher level of expression in group B than in group A and a lower level of expression in group C than in group B. CONCLUSIONS: DA-9701 may decrease visceral pain via the downregulation of p-ERK in the DRG and spinal cord.
Subject(s)
Animals , Male , Rats , Analgesics/pharmacology , Colon , Dilatation, Pathologic/physiopathology , Down-Regulation , Extracellular Signal-Regulated MAP Kinases/drug effects , Ganglia, Spinal/drug effects , Phytotherapy/methods , Plant Preparations/pharmacology , Proto-Oncogene Proteins c-fos/metabolism , Rats, Sprague-Dawley , Rectum , Spinal Cord/drug effects , Substance P/metabolism , Visceral Pain/prevention & controlABSTRACT
BACKGROUND/AIMS: Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS. METHODS: In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4. RESULTS: The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed. CONCLUSIONS: Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile.