1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Comparison of Chemoembolization Outcomes Using 70–150 µm and 100–300 µm Drug-Eluting Beads in Treating Small Hepatocellular Carcinoma: A Korean Multicenter Study
Byung Chan LEE ; Gyoung Min KIM ; Juil PARK ; Jin Wook CHUNG ; Jin Woo CHOI ; Ho Jong CHUN ; Jung Suk OH ; Dong Ho HYUN ; Jung Ho YANG
Korean Journal of Radiology 2024;25(8):715-725
Objective:
To evaluate the outcomes of drug-eluting bead transarterial chemoembolization (DEB-TACE) according to the size of the beads for the treatment of small hepatocellular carcinoma (HCC).
Materials and Methods:
This retrospective study included 212 patients with a single HCC ≤5 cm from five tertiary institutions. One hundred and nine patients were treated with 70–150-µm doxorubicin DEBs (group A), and 103 patients received 100–300-µm doxorubicin DEBs (group B). The initial tumor response (assessed between 3 weeks and 2 months after DEB-TACE), time to local tumor progression (TTLTP), restricted mean duration of complete response (RMDCR), rate of complications, incidence of post-embolization syndrome, and length of hospital stay were compared between the two groups.Logistic regression was used to analyze prognostic factors for initial tumor response.
Results:
The initial objective response rates were 91.7% (100/109) and 84.5% (87/103) for groups A and B, respectively (P = 0.101). In the subgroup analysis of tumors ≤3 cm, the initial objective response rates were 94.6% (53/56) and 78.0% (39/50) for groups A and B, respectively (P = 0.012). There was no significant difference in the TTLTP (median, 23.7 months for group A vs. 19.0 months for group B; P = 0.278 [log-rank], 0.190 [multivariable Cox regression]) or RMDCR at 24 months (11.4 months vs. 8.5 months, respectively; P = 0.088). In the subgroup analysis of tumors >3-cm, the RMDCR at 24 months was significantly longer in group A than in group B (11.8 months vs. 5.7 months, P = 0.024). The incidence of mild bile duct dilatation after DEB-TACE was significantly higher in group B than in group A (5.5% [6/109] vs. 18.4% [19/103], P = 0.003).
Conclusion
DEB-TACE using 70–150-µm microspheres demonstrated a higher initial objective response rate in ≤3-cm HCCs and a longer RMDCR at 24 months in 3.1–5-cm HCCs compared to larger DEBs (100–300-μm).
3.Body composition index obtained by using a bioelectrical impedance analysis device can be a predictor of prolonged operative time in patients undergoing minimally invasive colorectal surgery
Ho Seung KIM ; Kwang Ho KIM ; Gyoung Tae NOH ; Ryung-Ah LEE ; Soon Sup CHUNG
Annals of Coloproctology 2023;39(4):342-350
Purpose:
Obesity has been known to contribute to technical difficulties in surgery. Until now, body mass index (BMI) has been used to measure obesity. However, there are reports that BMI does not always correspond to the visceral fat. Recently, bioelectrical impedance analysis (BIA) has been used for body composition analysis. This study aimed to evaluate the usefulness of the body composition index obtained using a BIA device in predicting short-term postoperative outcomes.
Methods:
Data of patients who underwent elective major colorectal surgery using minimally invasive techniques were reviewed retrospectively. Body composition status was recorded using a commercial BIA device the day before surgery. The relationship between BMI, body composition index, and short-term postoperative outcomes, including operative time, was analyzed.
Results:
Sixty-six patients were enrolled in this study. In the correlation analysis, positive correlation was observed between BMI and body composition index. BMI and body composition index were not associated with short-term postoperative outcomes. Percent body fat (odds ratio, 4.226; 95% confidence interval [CI], 1.064–16.780; P=0.041) was found to be a statistically significant factor of prolonged operative time in the multivariate analysis. Correlation analysis showed that body fat mass was related to prolonged operative time (correlation coefficients, 0.245; P=0.048). In the area under curve analysis, body fat mass showed a statistically significant predictive probability for prolonged operative time (body fat mass: area, 0.662; 95% CI, 0.531–0.764; P=0.024).
Conclusion
The body composition index can be used as a predictive marker for prolonged operative time. Further studies are needed to determine its usefulness.
4.Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
Jun Sung MOON ; Il Rae PARK ; Hae Jin KIM ; Choon Hee CHUNG ; Kyu Chang WON ; Kyung Ah HAN ; Cheol-Young PARK ; Jong Chul WON ; Dong Jun KIM ; Gwan Pyo KOH ; Eun Sook KIM ; Jae Myung YU ; Eun-Gyoung HONG ; Chang Beom LEE ; Kun-Ho YOON
Diabetes & Metabolism Journal 2023;47(6):808-817
Background:
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods:
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results:
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.
5.Survival Rate and Prognostic Factors of 26 Cases of Angiosarcoma and 26 Cases of Kaposi Sarcoma: A Korean Single-Center Experience
Jin Seon BANG ; Nam Gyoung HA ; In Hee LEE ; Man-Hoon HAN ; Jeong Eun LEE ; Ho Yun CHUNG ; Dae-Lyong HA ; Seok-Jong LEE
Korean Journal of Dermatology 2023;61(8):472-480
Background:
Angiosarcoma (AS) and Kaposi sarcoma (KS) are rare malignant and borderline malignant vascular tumors that may first present to a dermatologist. There are few Korean studies that particularly focus on their survival due to low incidence.
Objective:
To investigate the survival and prognostic factors among patients with AS and KS, in addition to their clinical features.
Methods:
Between 2000∼2021, medical records of 26 AS and 26 KS patients at a single center were analyzed retrospectively. Additionally, we calculated the disease specific survival (DSS) and overall survival (OS) of two diseases.
Results:
The mean age of patients with AS was 72.9 years and 67.3 years for KS. The most common tumor location was the scalp in patients with AS (80.8%) and the foot (65.4%) in those with KS. In patients with AS, 1-year DSS and OS rates were 36.0% and 34.6%, respectively. Five-year DSS and OS rates were 24.0% and 20.2%, respectively. In patients with KS, the 1-year DSS and OS rates were 96.2% and 84.6%, respectively. The 5-year DSS and OS were 91.6% and 58.0%, respectively. Patients who were older or had larger lesions than average had decreased DSS and OS in AS. Among the patients with KS, immunosuppressed status, including human immunodeficiency virus infection, showed reduced OS.
Conclusion
Apart from confirming grave survival of AS and favorable survival of KS, patient’s age and size of lesion affect survival outcomes in patients with AS. Otherwise, immunosuppressed status affects survival outcomes in patients with KS.
6.Is restrictive transfusion sufficient in colorectal cancer surgery? A retrospective study before and during the COVID-19 pandemic in Korea
Hyeon Kyeong KIM ; Ho Seung KIM ; Gyoung Tae NOH ; Jin Hoon NAM ; Soon Sup CHUNG ; Kwang Ho KIM ; Ryung-Ah LEE
Annals of Coloproctology 2023;39(6):493-501
Purpose:
Blood transfusion is one of the most common procedures used to treat anemia in colorectal surgery. Despite controversy regarding the adverse effects of blood products, surgeons have maintained standards for administering blood transfusions. However, this trend was restrictive during the COVID-19 pandemic because of a shortage of blood products. In this study, we conducted an analysis to investigate whether the restriction of blood transfusions affected postoperative surgical outcomes.
Methods:
Medical records of 318 patients who underwent surgery for colon and rectal cancer at Ewha Womans University Mokdong Hospital between June 2018 and March 2022 were reviewed retrospectively. The surgical outcomes between the liberal and restrictive transfusion strategies in pre– and post–COVID-19 groups were analyzed.
Results:
In univariate analysis, postoperative transfusion was associated with infectious complications (odds ratio [OR], 1.705; 95% confidence interval [CI], 1.015–2.865; P=0.044). However, postoperative transfusion was not an independent risk factor for the development of infectious complications in multivariate analysis (OR, 1.305; 95% CI, 0.749–2.274; P=0.348). In subgroup analysis, there was no significant association between infectious complications and the hemoglobin threshold level for the administration of a transfusion (OR, 1.249; 95% CI, 0.928–1.682; P=0.142).
Conclusion
During colorectal surgery, the decision to perform a blood transfusion is an important step in ensuring favorable surgical outcomes. According to the results of this study, restrictive transfusion is sufficient for favorable surgical outcomes compared with liberal transfusion. Therefore, modification of guidelines is suggested to minimize unnecessary transfusion-related side effects and prevent the overuse of blood products.
7.Robotic single-incision right hemicolectomy with extended lymphadenectomy using the da Vinci SP Surgical Platform
Gyoung Tae NOH ; Soon Sup CHUNG ; Ryung-Ah LEE ; Kwang Ho KIM
Journal of Minimally Invasive Surgery 2021;24(2):109-112
The da Vinci SP Surgical System (dVSP; Intuitive Surgical, Sunnyvale, CA, USA) was introduced to overcome this limitation of single-incision laparoscopic surgery. This new surgical platform has been demonstrated favorable performance in colorectal surgery and its use has been increasing. And, in accordance with the increment of adoption of dVSP, the indication to apply this platform has been expanding. Herein, we report a technique of right hemicolectomy with extended lymphadenectomy beyond conventional lymph node dissection using dVSP.
8.Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis
Myungsu LEE ; Jin Wook CHUNG ; Kwang-Hun LEE ; Jong Yun WON ; Ho Jong CHUN ; Han Chu LEE ; Jin Hyoung KIM ; In Joon LEE ; Saebeom HUR ; Hyo-Cheol KIM ; Yoon Jun KIM ; Gyoung Min KIM ; Seung-Moon JOO ; Jung Suk OH
Korean Journal of Radiology 2021;22(10):1658-1670
Objective:
To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC).
Materials and Methods:
This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and perlesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed.
Results:
The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%).
Conclusion
DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.
9.Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis
Myungsu LEE ; Jin Wook CHUNG ; Kwang-Hun LEE ; Jong Yun WON ; Ho Jong CHUN ; Han Chu LEE ; Jin Hyoung KIM ; In Joon LEE ; Saebeom HUR ; Hyo-Cheol KIM ; Yoon Jun KIM ; Gyoung Min KIM ; Seung-Moon JOO ; Jung Suk OH
Korean Journal of Radiology 2021;22(10):1658-1670
Objective:
To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC).
Materials and Methods:
This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and perlesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed.
Results:
The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%).
Conclusion
DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.
10.Robotic single-incision right hemicolectomy with extended lymphadenectomy using the da Vinci SP Surgical Platform
Gyoung Tae NOH ; Soon Sup CHUNG ; Ryung-Ah LEE ; Kwang Ho KIM
Journal of Minimally Invasive Surgery 2021;24(2):109-112
The da Vinci SP Surgical System (dVSP; Intuitive Surgical, Sunnyvale, CA, USA) was introduced to overcome this limitation of single-incision laparoscopic surgery. This new surgical platform has been demonstrated favorable performance in colorectal surgery and its use has been increasing. And, in accordance with the increment of adoption of dVSP, the indication to apply this platform has been expanding. Herein, we report a technique of right hemicolectomy with extended lymphadenectomy beyond conventional lymph node dissection using dVSP.

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