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.
Compliance ; Dyspepsia* ; Humans

BACKGROUND/AIMS: The discrepancy of the histopathological diagnosis between endoscopic forcep biopsy, surgery and endoscopic mucosal resection (EMR), has been reported on in a previous study. We compared the results of endoscopic forcep biopsy and the histopathologic diagnosis after performing endoscopic submucosal dissection (ESD). METHODS: We retrospectively reviewed 434 lesions for which we were able to compare the post-ESD histopathologic results with the endoscopic biopsy. RESULTS: 1) Of the 14 lesions that showed chronic gastritis or atypia by endoscopic biopsy, 9 were diagnosed with carcinoma in situ or adenocarcinoma after ESD. 2) fifty one of 141 lesions that showed low grade dysplasia on the endoscopic biopsy were diagnosed with carcinoma in situ or adenocarcinoma after ESD. 3) Of the 60 lesions that showed high grade dysplasia on the endoscopic biopsy, 46 were diagnosis with carcinoma in situ or adenocarcinoma after ESD. CONCLUSIONS: The discrepancy of the histopathological diagnosis was found between ESD and forcep biopsy. In light of these results, if a lesion that is suspected to be EGC, although it is not diagnosed by endoscopic biopsy, then it should be confirmed by ESD.
Adenocarcinoma ; Biopsy ; Carcinoma in Situ ; Gastritis ; Light ; Retrospective Studies ; Surgical Instruments

PURPOSE: N-13 ammonia uptake and retention in the myocardium is related to perfusion and metabolism. There are several potential advantages of N-13 ammonia positron emission tomography (PET) to detect myocardial ischemia, such as higher spatial resolution, greater counting efficiencies, and robust attenuation correction. But there are few reports comparing Tc-99m myocardial perfusion single photon emission tomography (MPS) and N-13 ammonia PET. We thus compared adenosine stress N-13 ammonia PET/CT and Tc-99m sestamibi MPS in patients with suspected coronary artery stenosis. MATERIALS AND METHODS: Seventeen patients (male 13 : 63+/-11 years old) underwent adenosine stress N-13 ammonia PET/CT (Discovery ST, GE), Tc-99m sestamibi MPS (dual head gamma camera, Hawkeye, GE) and coronary angiography within 1 week. N-13 ammonia PET/CT and Tc-99m sestamibi MPS images were assessed with a 20-segment model by visual interpretation and quantitative analysis using automatic quantitative software (Myovation, GE). RESULTS: Both sensitivities and specificities of detecting an individual coronary artery stenosis were higher for N-13 ammonia PET/CT than Tc-99m sestamibi MPS (PET/CT: 91%/ 89% vs MPS: 65%/ 82%). N-13 ammonia PET/CT showed reversibility in 52% of segments that were considered non-reversibile by Tc-99m sestamibi MPS. In the 110 myocardial segments supplied by the stenotic coronary artery, N-13 ammonia PET/CT showed higher count densities than Tc-99m MPS on rest study (p<0.01), and the difference of count density between the stress and the rest studies was also larger on N-13 ammonia PET/CT. CONCLUSION: Adenosine stress N-13 ammonia PET/CT had higher diagnostic sensitivity and specificity, more reversibility of perfusion defects and greater stress/rest uptake differences than Tc-99m sestamibi MPS. Accordingly, N-13 ammonia PET/CT might offer better assessment of myocardial ischemia and viability.
Adenosine ; Ammonia ; Coronary Angiography ; Coronary Artery Disease ; Coronary Stenosis ; Coronary Vessels ; Gamma Cameras ; Head ; Humans ; Myocardial Ischemia ; Myocardium ; Perfusion ; Positron-Emission Tomography ; Retention (Psychology) ; Sensitivity and Specificity ; Tomography, Emission-Computed, Single-Photon

BACKGROUND AND OBJECTIVES: Percutaneous coronary intervention (PCI) for unprotected left main coronary artery (LMCA) stenosis is a promising technique in the drug-eluting stent era. However, there is a lack of data as to the impact of the lesion location in the LMCA on the procedural and postprocedural outcomes. The aim of this study is to evaluate the effect of lesion location on the procedural and postprocedural outcomes. SUBJECTS AND METHODS: From July 2003 to January 2006, we enrolled 82 patients (Males: n=49), who underwent PCI for unprotected LMCA stenosis at Yeungnam University Medical Center, Keimyung University Dong-san Hospital and In-je University Baik Hospital in Busan. The patients were divided into two groups according to the lesion location. Group 1 (n=38) was defined as those patients who had a significant stenosis in the ostium and/or body. Group 2 (n=44) was defined as those patients had a left main coronary lesion involving a bifurcation. All the patients had a sirolimus eluting stent (Cypher, Cordis) deployed into the LMCA stenosis. Stenting techniques such as the T, crush and kissing stent techniques for treating the LMCA were used at the discretion of the operator and according to the characteristics of the lesion location. The in-hospital outcomes were compared between the two groups and follow-up coronary angiography was performed after 6 months; the major adverse cardiac events (MACE) and restenosis were analyzed between the two groups. RESULTS: The baseline characteristics between the two groups were not statistically different. The procedural outcomes showed that for the stenting methods, the conventional stent technique was the only one used in all cases of Group 1, but the kissing, T stenting and Crush techniques were also used in Group 2 (p=0.001). The clinical outcomes showed that that there was no statistical difference for the in-hospital MACEs between the two groups, but for the out-of hospital MACEs at 6 month, the target lesion revascularizatin rates, including PCI or bypass graft operation, in Group 1 were higher than those in Group 2 (0% vs 13.6%, respectively p=0.043). Both groups had one cardiac death each (2.3% vs 2.6% respectively) and there was 1 MACE in Group 1 and 7 MACEs in Group 2 (2.6% vs 16%, respectively, p=0.045). The angiographic outcomes at 6 month showed that all 8 significant restenosis cases were included in Group 2 (18%, 9.7% in the total population); the restenosis site was the left circumflex artery in all cases. CONCLUSION: PCI with using drug eluting stents in the left main lesion showed favorable short term outcomes in selected patients. The lesion location is also an important factor for the clinical and angiographical outcomes.
Academic Medical Centers ; Angioplasty ; Arteries ; Busan ; Constriction, Pathologic ; Coronary Angiography ; Coronary Disease ; Coronary Vessels ; Death ; Drug-Eluting Stents ; Follow-Up Studies ; Humans ; Percutaneous Coronary Intervention ; Sirolimus ; Stents* ; Transplants ; Treatment Outcome

BACKGROUND: Double balloon enteroscopy was developed to improve access to the small intestine. The aim of this study was to evaluate the efficacy of double balloon enteroscopy in patients with obscure gastrointestinal bleeding. METHODS: From November 2004 through August 2005, 24 consecutuve patients (14 males, 10 females; mean age 48+/-15.1 years, range 2181 years) with gastrointestinal bleeding of an obscure origin were enrolled in this study. The patients underwent enteroscopy using the double balloon technique for the following indications: (1) clinical evidence of gastrointestinal bleeding such as melena and hematochezia (the Hb levels ranged from 5.9 g/dL to 11.9 g/dL, mean 9.0+/-2.3 g/dL) (2) no site and cause of blood loss detected by upper endoscopy and colonoscopy. RESULTS: Of 24 patients that underwent a double balloon enteroscopy, bleeding points were identified in 22 patients. The causes of bleeding were nine small bowel ulcera, six angiodysplasiaa, three cases of Crohn's disease, two gastrointestinal stromal tumors, one Meckel's diverticulum and one cecal diverticular ulcer. However, two cases showed negative findings. No patient suffered from procedure related complication. CONCLUSIONS: Double balloon enteroscopy is a safe and useful diagnostic tool for obscure gastrointestinal bleeding.
Colonoscopy ; Crohn Disease ; Double-Balloon Enteroscopy* ; Endoscopy ; Female ; Gastrointestinal Hemorrhage ; Gastrointestinal Stromal Tumors ; Hemorrhage* ; Humans ; Intestine, Small ; Male ; Meckel Diverticulum ; Melena ; Ulcer

BACKGROUND: We tried to assess whether the presence of warning symptoms and age could be useful indicators for performing endoscopy in patients who suffer from various organic gastrointestinal diseases. METHODS: Between May 2005 to August 2005, 827 subjects who visited the health care center were studied via questionnaires and performing upper endoscopy. The questionnaires evaluated the presence and pattern of dyspepsia and the warning symptoms. RESULTS: A total of 808 patients were enrolled. The mean age of patients was 44.6+/-8.9 years (mean+/-SD) with a male to female ratio of 1.2:1. 153 patients (18.9%) were diagnosed with confirmed organic diseases and 52 patients (6.4%) were diagnosed with definite organic diseases. The total number of organic diseases and definite organic diseases (gastroduodenal ulcer, reflux esophagitis and advanced gastric cancer) was statistically higher in the male population (p=0.001 in both). The relative risk of dyspepsia, the presence of warning symptoms and each warning symptom for the organic disease and definite organic diseases were not consistently higher for the males or females. The males over fifty years and the males over sixty years age had a relative risk of 2.046 (95% CI: 1.27~3.30) and 3.105 (95% CI: 1.39~6.95) for organic disease and 1.913 (95% CI: 0.97~3.77) and 5.333 (95% CI: 2.15~13.22) for definite organic disease, respectively. For the male patients over fifty or sixty years old with dyspepsia or warning symptoms, there were tendencies to increase the relative risk of definite organic disease rather than organic disease. CONCLUSIONS: The relative risk of organic diseases in the presence of warning symptoms in males of over fifty years or sixty years age was not sufficiently significant for differentiating organic diseases. Thus, warning symptoms, old age and presence of dyspepsia alone can not be used as a predictor to guide endoscopic examination.
Delivery of Health Care ; Dyspepsia* ; Endoscopy ; Esophagitis, Peptic ; Female ; Gastrointestinal Diseases ; Humans ; Male ; Ulcer ; Surveys and Questionnaires

BACKGROUND/AIMS: Although various solutions are being tested for submucosal injection during endoscopic resection, ideal solution has not been established yet. We performed an animal study to evaluate the possibility of sodium alginate as an ideal submucosal injection solution for endoscopic mucosal resection (EMR). METHODS: To compare the lesion-lifting properties of different solutions, injection was done to the submucosal layer of porcine stomach. Then the height of mucosal elevation was measured. In addition, EMR was performed after submucosal injection of sodium alginate solution in six dogs. Two were euthanized after 30 minutes of endoscopic observation while the others were euthanized after 1-4 weeks. Retrieved stomachs were examined microscopically. RESULTS: Sodium alginate and sodium hyaluronate solutions maintained longer elevation of the submucosal layer than other solutions. There was no significant difference in the height between two solutions. A clear separation of the mucosal layer from the proper muscle layer was achieved by injecting sodium alginate solution. Histological examination of EMR-induced artificial ulcers revealed no apparent tissue damage and showed normal healing process. CONCLUSIONS: Sodium alginate solution creates a sufficient submucosal fluid cushion without apparent tissue damage. It can be considered as an effective submucosal injection material.
Animals* ; Dogs ; Hyaluronic Acid ; Sodium* ; Stomach ; Ulcer

BACKGROUND/AIMS: A gastrointestinal mesenchymal tumor contains a leiomyoma and gastrointestinal stromal tumor (GIST). The natural course can vary according to the histology and other characteristics. This study evaluated the natural course of a benign mesenchymal tumor in the upper gastrointestinal tract using endoscopic ultrasonography (EUS). METHODS: Submucosal mesenchymal tumors are considered benign according to the following criteria of EUS: 1) the tumor originates from the muscularis mucosa or muscularis propria; 2) is well demarcated, homogenous and hypoechoic; and 3) has a regular surface. In this study, the changes of size, internal echo pattern and marginal regularity were evaluated retrospectively in 26 lesions that all were < 3 cm and were followed up for more than 2 years. RESULTS: The average size of the tumors on EUS was 11.5 mm. The mean follow-up period was 47.4 months. The follow-up EUS revealed no change in echo features in any patient. In only one patient, the size of the tumor increased from 26 to 34 mm without a change in the internal echo or marginal regularity after 24 months. This patient underwent a laparoscopic gastric wedge resection. The pathologic diagnosis was a leiomyoma. CONCLUSIONS: Most small submucosal tumors that are compatible with the EUS criteria of a benign GIST/ leiomyoma do not change over a period of 24 months, and the EUS criteria are effective in diagnosing benign GISTs/leiomyomas. A benign GIST/leiomyoma at EUS might be followed up by EUS at an interval of 2 years.
Diagnosis ; Endosonography ; Follow-Up Studies ; Gastrointestinal Stromal Tumors ; Humans ; Leiomyoma ; Mucous Membrane ; Retrospective Studies ; Upper Gastrointestinal Tract*

BACKGROUND AND OBJECTIVES: Percutaneous coronary intervention (PCI) of unprotected left main coronary artery (LMCA) stenosis is a promising approach during this era of drug-eluting stents. However, there is no available hemodynamic data on these type patients during the performance of LMCA stenting. The purpose of this study was to determine the risk factors affecting hemodynamic stability during LMCA stenting, and to evaluate whether hemodynamic support such as inotropics or intra-aortic balloon pump (IABP) is needed, based on the risk factors. SUBJECTS AND METHODS: From July 2003 to January 2006, we enrolled 92 study patients (Male=55) who had visited Yeungnam University Hospital, Keimyung University Dongsan Hospital and InJe University Baik Hospital in Busan and they were all were diagnosed with angiographically detected unprotected LMCA stenosis. Group 1 (n=69) included those patients who did not need hemodynamic support during PCI. Group 2 (n=23) included patients who needed hemodynamic support during PCI. All patients had stents deployed in the LMCA lesions without hemodynamic support; the clinical, angiographic and procedural outcomes were compared between the two groups after the procedure. RESULTS: The baseline patient characteristics were not statistically different between the two groups. On univariate analysis, Group 2 had more patients diagnosed with acute myocardial infarction (AMI) than Group 1 (40% vs. 15%, respectively, p=0.014). Group 1 had a greater frequency of an increased left ventricular (LV) ejection fraction than Group 2 (60+/-10 vs. 47+/-11, respectively, p=0.01). Regarding the lesion location in the LMCA, Group 2 had relatively more lesions at bifurcated locations than Group 1 (44% vs. 78%, respectively, p=0.004). Group 2 required more complex techniques to repair lesions, such as kissing or crush stenting, than did Group 1 (19% vs. 48%, respectively, p=0.006). Multivariate logistic regression analysis showed that the presence of AMI (Odds Ratio (OR)=3.74, p=0.014), a complex stenting procedure such as kissing or crushing (OR=3.99, p=0.006), a bifurcated lesion (OR=4.58, p=0.004) and poor LV function (OR=9.95, p=0.0001) were independent risk factors for hemodynamic instability during LMCA stenting. CONCLUSION: The most important risk factor for hemodynamic instability during LMCA stenting was LV function. Therefore, preparation for hemodynamic support, including IABP before the procedure, is necessary for the high risk patients.
Busan ; Constriction, Pathologic ; Coronary Vessels ; Drug-Eluting Stents ; Hemodynamics* ; Humans ; Logistic Models ; Myocardial Infarction ; Percutaneous Coronary Intervention ; Risk Factors* ; Stents* ; Ventricular Function

BACKGROUND/AIMS: We investigated the clinical significance of the criteria of the absolute and relative depth of invasion for submucosal invasive colorectal carcinomas. METHODS: We analyzed retrospectively the clinicopathological features of 29 submucosal invasive colorectal cancers. The relative depth of submucosal invasion was evaluated by a relative (sm1, 2, 3) classification and the absolute depth of submucosal invasion was measured in micrometers from the lower border of the muscularis mucosa to the deepest cancer gland. RESULTS: All sm1 cancers showed a submucosal layer invasion of less than 1,000micronm; invasion was seen between 500micronm and 1,000micronm. The rate of lymphovascular invasion was higher for sm1c, sm2 and sm3 than for sm1a and sm1b, and the rate of invasion was higher for a level of 500micronm or more than for a level of 500micronm or less for the depth of submucosal invasion. One of sixteen patients that underwent surgery showed lymph node involvement. For this patient, the relative depth of invasion was sm1c and the absolute depth was 900micronm. CONCLUSIONS: Endoscopically treated submucosal colorectal cancer needs to be evaluated by the absolute depth in addition to the relative depth. It seems that a submucosal invasive cancer less than 500micronm in submucosal depth probably can be treated by endoscopic resection.
Classification* ; Colon* ; Colonic Neoplasms ; Colorectal Neoplasms ; Humans ; Lymph Nodes ; Mucous Membrane ; Retrospective Studies