BACKGROUND/AIMS: Second-look endoscopy is performed to check for the possibility of post-endoscopic submucosal dissection (ESD) bleeding and to perform prophylactic hemostasis in most hospitals; however, there is little evidence about the efficacy of second-look endoscopy. We investigated whether second-look endoscopy after ESD is useful in the prevention of post-ESD bleeding. METHODS: A total of 550 lesions with gastric epithelial neoplasms in 502 patients (372 men and 130 women) were treated with ESD between August 18, 2009 and August 18, 2010. After the exclusion of three lesions of post-ESD bleeding within 24 hours, 547 lesions (335 early gastric cancers and 212 gastric adenomas) were included for the final analysis. RESULTS: The occurrence rate of delayed post-ESD bleeding was not significantly different between the second-look group and the no second-look group (1% vs 2.5%, p>0.05). The only predictor of delayed bleeding was tumor size, regardless of second-look endoscopy after ESD (22.8+/-9.87 vs 15.1+/-10.47, p<0.05). There was no difference between the prophylactic hemostasis and nonprophylactic hemostasis groups, including the occurrence rate of delayed bleeding. In the second-look group with prophylactic hemostasis, the hospital stay was more prolonged than in the second-look group without prophylactic hemostasis, but there was no significant difference (p=0.08). CONCLUSIONS: Second-look endoscopy to prevent delayed bleeding after ESD provides no significant medical benefits.
Adult ; Aged ; Aged, 80 and over ; Female ; Gastrectomy/adverse effects ; Gastric Mucosa/surgery ; *Gastroscopy ; Humans ; Length of Stay ; Male ; Middle Aged ; Postoperative Hemorrhage/*diagnosis/etiology ; Retrospective Studies ; Risk Factors ; Second-Look Surgery ; Stomach/pathology/surgery ; Stomach Neoplasms/pathology/*surgery ; Time Factors

The serious complication after endoscopic mucosal resection (EMR) was bleeding and perforation. Most of bleedings could be controlled by endoscopic procedure. However, the strategy of treatment for perforation was not established. A 60-year-old man was admitted to our center for EMR of gastric adenomatous lesion. After EMR, perforation in stomach was detected by peumoperitoneum on plain upright chest X-ray. We treated with conservative management such as withholding of oral intake, administration of broad-spectrum antibiotics, parenteral nutrition and close monitoring. There were no worsening clinical sings of peritoneal inflammation except mild leukocytosis during the in-hospital course. On the third hospital day after EMR, the patient resumed oral intake. The seventh hospital day, he was discharged. Our experience showed that selected small microperforation in stomach after EMR could be treated by not endoscopic procedures or surgical interventions but conservative management.
Anti-Bacterial Agents ; Hemorrhage ; Humans ; Inflammation ; Intestinal Perforation ; Leukocytosis ; Middle Aged ; Parenteral Nutrition ; Stomach* ; Thorax

OBJECTIVE: Intracavitary injection of beta-emitting radiation source for control of cystic tumors has been tried with a benefit of localized internal radiation. The authors treated cystic brain tumor patients with Holmium-166-chitosan complex (Ho-166-chico), composed of a beta-emitting radionuclide Holmium-166 and biodegradable chit polymer, and evaluated the safety and effective measurement for response. METHODS: Twenty-two patients with recurrent cystic brain tumor and/or located in a deep or eloquent area were enrolled in this pilot study. The cyst volume and wall thickness were determined on CT or MRI to assess radiological response. The activity of Ho-166-chico injected via Ommaya reservoir was prescribed to be 10-25 Gy to the cyst wall in a depth of 4 mm. RESULTS: There was neither complications related to systemic absorption nor leakage of Ho-166-chico in all 22 patients. But, two cases of oculomotor paresis were observed in patients with recurrent craniopharyngioma. Radiological response was seen in 14 of 20 available follow-up images (70%). Seven patients of 'evident' radiological response experienced more than 25% decrease of both cyst volume and wall thickness. Another 7 patients with 'suggestive' response showed decrease of cyst volume without definitive change of the wall thickness or vice versa. All patients with benign tumors or low grade gliomas experienced symptomatic improvement. CONCLUSION: Ho-166-chico intracavitary radiation therapy for cystic tumor is a safe method of palliation without serious complications. The determination of both minimal effective dosage and time interval of repeated injection through phase 1 trial could improve the results in the future.
Absorption ; Brain Neoplasms* ; Brain* ; Chitosan ; Craniopharyngioma ; Follow-Up Studies ; Glioma ; Holmium ; Humans ; Paresis ; Pilot Projects* ; Polymers

BACKGROUND: We aimed to evaluate the performance of serum cystatin C-based equations in calculating the glomerular filtration rate (GFR) in patients with varying stages of chronic kidney disease (CKD). METHODS: Serum cystatin C and creatinine levels were measured in 615 CKD patients. The CKD stage was determined by the creatinine-based estimated GFR (eGFR) equation using the four-variable abbreviated Modification of Diet in Renal Disease equation suggested by the Kidney Disease Outcome Quality Initiative with the addition of a coefficient applicable to Korean populations (K-aMDRD). In each CKD stage, the ratio of serum cystatin C to creatinine was calculated and six different cystatin C-based equations were used to estimate GFR. Cystatin C-based eGFR and aMDRD eGFR values were compared using the paired t test, Pearson correlation test, and the Bland-Altman plot. RESULTS: The mean age of patients was 53.21+/-14.45 years; of the 615 patients, 346 were male. The serum cystatin C-to-creatinine ratio was inversely correlated with the CKD stage. Compared with the K-aMDRD values, the results of the Hoek, Filler, and Le Bricon's cystatin C-based eGFR equations were lower in CKD Stages 1-3 and higher in Stages 4 and 5. However, the results of the Orebro-cystatin (Gentian) equation [GFR=100/ScytC (mL/minute/1.73m2) - 14] were similar to those of the K-aMDRD equation in CKD Stages 4 and 5 (15.44+/-9.45 vs. 15.17+/-9.05mL/minute/1.73m2, respectively; P=0.722; bias=0.27+/-8.87). CONCLUSION: The eGFRs obtained from the six cystatin C-based equations differed widely. Therefore, further studies are required to determine the most accurate equation to estimate GFR in Koreans with CKD.
Creatinine ; Cystatin C ; Diet ; Glomerular Filtration Rate* ; Humans ; Kidney Diseases ; Male ; Renal Insufficiency, Chronic*

PURPOSE: The purpose of this study was to compare the diagnostic accuracies of chest radiographs and chest CTin the diagnosis of a solitary pulmonary nodule(SPN), and to determine the role of CT and CT findings which aid inthe differential diagnosis of nodules. MATERIALS AND METHODS: A retrospective study was done on 54 patients inwhom SPN was found on chest radiographs and chest CT was carried out. The study involved 25 benign and 29 malignant nodules, confirmed histopathologically and clinically. Chest radiographs and CT scans were reviewed separately in randomized order by two chest radiologists who for each film listed the three most likely diagnose sin descending order. The radiologists recorded the confidence value of the most probable diagnosis, and also the marginal and internal characteristics of nodules and their size, as nodules seen on chest CT scans. RESULTS: Diagnostic rates in the differential diagnosis of benign and malignant nodules were 65.7% by radiography and 77.8% by CT. Correct first-choice diagnosis was by radiography in 30.6 % of cases, and by CT in 41.7%. Using radiographs, and the correct diagnosis was among the top-three choices in 61.1% of cases ; with CT, the corresponding figure was 76.8%. Overall, a confident diagnosis was reached more often with the CT(41.7%) than with the chest radiograph(21.4%) ; diagnaotic accuracy was 60.0% and 52.2%, respectively. CT findings which imply abenign nodule include smooth margins and diffuse internal calcifications, whereas marginal lobulations, air-bronchograms, internal low density without cavitation, eccentric calcifications, and large size suggest malignancy. We faund that CT findings such as well-defined margins, spiculations, pleural tail or internal homogeneity did not contribute in the differentiation between benign and malignant nodules. CONCLUSION: CT issuperior to chest radiography in the differential diagnosis of the solitary pulmonary nodule. Using CT, diagnosis was accurate and made with a high level of confidence, especially with the application of CT findings which aid inthe differential diagnosis of nodules.
Diagnosis ; Diagnosis, Differential* ; Humans ; Radiography* ; Radiography, Thoracic ; Retrospective Studies ; Solitary Pulmonary Nodule* ; Thorax* ; Tomography, X-Ray Computed

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission.Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

Background: Recent diabetes management guidelines recommend that sodium-glucose cotransporter 2 inhibitors (SGLT2is) or glucagon-like peptide 1 receptor agonists (GLP-1RAs) with proven cardiovascular benefits should be prioritized for combination therapy in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD). This study was aimed at evaluating SGLT2i or GLP-1RA usage rates and various related factors in patients with T2DM and established CVD. Methods: We enrolled adults with T2DM aged ≥30 years who were hospitalized due to established CVD from January 2019 to May 2020 at 13 secondary and tertiary hospitals in Korea in this retrospective observational study. Results: Overall, 2,050 patients were eligible for analysis among 2,107 enrolled patients. The mean patient age, diabetes duration, and glycosylated hemoglobin level were 70.0 years, 12.0 years, and 7.5%, respectively. During the mean follow-up duration of 9.7 months, 25.7% of the patients were prescribed SGLT2is after CVD events. However, only 1.8% were prescribed GLP-1RAs. Compared with SGLT2i non-users, SGLT2i users were more frequently male and obese. Furthermore, they had a shorter diabetes duration but showed worse glycemic control and better renal function at the time of the event. GLP-1RA users had a longer duration of diabetes and worse glycemic control at the time of the event than GLP-1RA non-users. Conclusion The SGLT2i or GLP-1RA prescription rates were suboptimal in patients with T2DM and established CVD. Sex, body mass index, diabetes duration, glycemic control, and renal function were associated with the use of these agents.

Background: Recent diabetes management guidelines recommend that sodium-glucose cotransporter 2 inhibitors (SGLT2is) or glucagon-like peptide 1 receptor agonists (GLP-1RAs) with proven cardiovascular benefits should be prioritized for combination therapy in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD). This study was aimed at evaluating SGLT2i or GLP-1RA usage rates and various related factors in patients with T2DM and established CVD. Methods: We enrolled adults with T2DM aged ≥30 years who were hospitalized due to established CVD from January 2019 to May 2020 at 13 secondary and tertiary hospitals in Korea in this retrospective observational study. Results: Overall, 2,050 patients were eligible for analysis among 2,107 enrolled patients. The mean patient age, diabetes duration, and glycosylated hemoglobin level were 70.0 years, 12.0 years, and 7.5%, respectively. During the mean follow-up duration of 9.7 months, 25.7% of the patients were prescribed SGLT2is after CVD events. However, only 1.8% were prescribed GLP-1RAs. Compared with SGLT2i non-users, SGLT2i users were more frequently male and obese. Furthermore, they had a shorter diabetes duration but showed worse glycemic control and better renal function at the time of the event. GLP-1RA users had a longer duration of diabetes and worse glycemic control at the time of the event than GLP-1RA non-users. Conclusion The SGLT2i or GLP-1RA prescription rates were suboptimal in patients with T2DM and established CVD. Sex, body mass index, diabetes duration, glycemic control, and renal function were associated with the use of these agents.

Background: Recent diabetes management guidelines recommend that sodium-glucose cotransporter 2 inhibitors (SGLT2is) or glucagon-like peptide 1 receptor agonists (GLP-1RAs) with proven cardiovascular benefits should be prioritized for combination therapy in patients with type 2 diabetes mellitus (T2DM) and established cardiovascular disease (CVD). This study was aimed at evaluating SGLT2i or GLP-1RA usage rates and various related factors in patients with T2DM and established CVD. Methods: We enrolled adults with T2DM aged ≥30 years who were hospitalized due to established CVD from January 2019 to May 2020 at 13 secondary and tertiary hospitals in Korea in this retrospective observational study. Results: Overall, 2,050 patients were eligible for analysis among 2,107 enrolled patients. The mean patient age, diabetes duration, and glycosylated hemoglobin level were 70.0 years, 12.0 years, and 7.5%, respectively. During the mean follow-up duration of 9.7 months, 25.7% of the patients were prescribed SGLT2is after CVD events. However, only 1.8% were prescribed GLP-1RAs. Compared with SGLT2i non-users, SGLT2i users were more frequently male and obese. Furthermore, they had a shorter diabetes duration but showed worse glycemic control and better renal function at the time of the event. GLP-1RA users had a longer duration of diabetes and worse glycemic control at the time of the event than GLP-1RA non-users. Conclusion The SGLT2i or GLP-1RA prescription rates were suboptimal in patients with T2DM and established CVD. Sex, body mass index, diabetes duration, glycemic control, and renal function were associated with the use of these agents.