1.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
2.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
3.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
4.Korean vs. Western Exercise Capacity Nomograms for Korean Patients With Cardiovascular Disease
Soohyung PARK ; Byambakhand BATTUMUR ; Seo Yeon YOON ; Yohan LEE ; Se hyun PARK ; Kyuho LEE ; Seungmin BACK ; Jieun LEE ; Dong Oh KANG ; Jah Yeon CHOI ; Seung-Young ROH ; Jin Oh NA ; Cheol Ung CHOI ; Jin Won KIM ; Seung-Woon RHA ; Chang Gyu PARK ; Eung Ju KIM
Journal of Korean Medical Science 2023;38(23):e179-
Background:
Exercise capacity is known to be an independent predictor of cardiovascular events and mortality. However, most previous studies were based on Western populations.Further study is warranted for Asian patients according to ethnic or national standards. We aimed to compare prognostic values of Korean and Western nomograms for exercise capacity in Korean patients with cardiovascular disease (CVD).
Methods:
In this retrospective cohort study, we enrolled 1,178 patients (62 ± 11 years;78% male) between June 2015 and May 2020, who were referred for cardiopulmonary exercise testing in our cardiac rehabilitation program. The median follow-up period was 1.6 years. Exercise capacity was measured in metabolic equivalents by direct gas exchange method during the treadmill test. The nomogram for exercise capacity from healthy Korean individuals and a previous landmark Western study was used to determine the percentage of predicted exercise capacity. The primary endpoint was the composite of major adverse cardiovascular events (MACE; all-cause death, myocardial infarction, repeat revascularization, stroke and hospitalization for heart failure).
Results:
A multivariate analysis showed that the risk of primary endpoint was more than double (hazard ratio [HR], 2.20; 95% confidence interval [CI], 1.10–4.40) in the patients with lower exercise capacity (< 85% of predicted) by Korean nomogram. The lower exercise capacity was one of the strong independent predictors along with left ventricular ejection fraction, age, and level of hemoglobin. However, the lower exercise capacity by Western nomogram could not predict the primary endpoint (HR, 1.33; 95% CI, 0.85–2.10).
Conclusion
Korean patients with CVD with lower exercise capacity have higher risk of MACE.Considering inter-ethnic differences in cardiorespiratory fitness, the Korean nomogram provides more suitable reference values than the Western nomogram to determine lower exercise capacity and predict cardiovascular events in Korean patients with CVD.
5.The Incidence and Impact of Abdominal Surgery on Delirium in Abdominal Trauma Patients
Hyun Seok ROH ; Yun Cheol PARK ; Young Goun JO ; Jung Chul KIM
Journal of Acute Care Surgery 2020;10(2):42-46
Purpose:
The occurrence of trauma-related delirium following postoperative abdominal surgery is associated with a poor prognosis. The purpose of this study was to identify predictive risk factors for trauma-related delirium.
Methods:
Trauma patient data from a regional trauma center were retrospectively collected from August 2015 to December 2016. The primary inclusion criteria were patients diagnosed with traumarelated delirium following abdominal trauma surgery. Head trauma patients and those under 18 years of age were excluded from this study. A multivariate logistic regression analysis was performed to identify the risk factors associated with trauma-related delirium.
Results:
Of the 255 trauma patients who met the inclusion criteria, 32 (12.5%) were diagnosed with delirium. The mean values for the age of the patients, Injury Severity Score, Glasgow Coma Scale score, and length of intensive care unit stay were 52.1 ± 17.8 years, 16.9, 14, and 7.1 days, respectively. Among the measured parameters, age [odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01-1.06; p = 0.022)], sex (OR, 0.125; 0.03-0.55; p = 0.006), hemoglobin level (OR, 0.875; CI, 0.68-0.98; p = 0.03), length of stay in the intensive care unit (OR, 1.12; CI, 1.03-1.22; p = 0.01), and having an abdominal operation (OR, 2.92; CI, 1.10-7.23; p = 0.011) showed strong correlations with trauma-related delirium.
Conclusion
This study showed that abdominal surgery was strongly associated with delirium in patients with traumatic abdominal injury. Thus, changes in consciousness should be carefully monitored following surgery.
6.The Incidence and Impact of Abdominal Surgery on Delirium in Abdominal Trauma Patients
Hyun Seok ROH ; Yun Cheol PARK ; Young Goun JO ; Jung Chul KIM
Journal of Acute Care Surgery 2020;10(2):42-46
Purpose:
The occurrence of trauma-related delirium following postoperative abdominal surgery is associated with a poor prognosis. The purpose of this study was to identify predictive risk factors for trauma-related delirium.
Methods:
Trauma patient data from a regional trauma center were retrospectively collected from August 2015 to December 2016. The primary inclusion criteria were patients diagnosed with traumarelated delirium following abdominal trauma surgery. Head trauma patients and those under 18 years of age were excluded from this study. A multivariate logistic regression analysis was performed to identify the risk factors associated with trauma-related delirium.
Results:
Of the 255 trauma patients who met the inclusion criteria, 32 (12.5%) were diagnosed with delirium. The mean values for the age of the patients, Injury Severity Score, Glasgow Coma Scale score, and length of intensive care unit stay were 52.1 ± 17.8 years, 16.9, 14, and 7.1 days, respectively. Among the measured parameters, age [odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01-1.06; p = 0.022)], sex (OR, 0.125; 0.03-0.55; p = 0.006), hemoglobin level (OR, 0.875; CI, 0.68-0.98; p = 0.03), length of stay in the intensive care unit (OR, 1.12; CI, 1.03-1.22; p = 0.01), and having an abdominal operation (OR, 2.92; CI, 1.10-7.23; p = 0.011) showed strong correlations with trauma-related delirium.
Conclusion
This study showed that abdominal surgery was strongly associated with delirium in patients with traumatic abdominal injury. Thus, changes in consciousness should be carefully monitored following surgery.
7.Seroepidemiology of Hepatitis Viruses and Hepatitis B Genotypes of Female Marriage Immigrants in Korea.
Jae Cheol KWON ; Hye Young CHANG ; Oh Young KWON ; Ji Hoon PARK ; In Soo OH ; Hyung Joon KIM ; Jun Hyung LEE ; Ha Jung ROH ; Hyun Woong LEE
Yonsei Medical Journal 2018;59(9):1072-1078
PURPOSE: The Korean society has moved rapidly toward becoming a multicultural society. This study aimed to estimate the seroprevalence of hepatitis viruses and investigate hepatitis B virus (HBV) genotypic diversity in female marriage immigrants. MATERIALS AND METHODS: Screening program was conducted at support centers for multicultural families in 21 administrative districts in Korea between July 2011 and January 2017. A total of 963 female marriage immigrants were included in this study. Blood samples were tested for hepatitis viral markers and HBV genotype. RESULTS: Subjects' median age was 33 years (20–40 years), and they originated from nine countries including Vietnam (n=422, 43.8%), China (n=311, 32.3%), the Philippines (n=85, 8.8%), Cambodia (n=58, 6.0%), and Japan (n=39, 4.0%). About 30% (n=288) of subjects required hepatitis A vaccination. HBsAg positive rate was 5.4% (n=52). Positive HBsAg results were the highest in subjects from Southeast Asia (6.6%, n=38). Anti-HBs positive rate was 60.4% (n=582). About 34% (n=329) of subjects who were negative for anti-HBs and HBsAg required HBV vaccinations. Genotypes B and C were found in 54.6% (n=12) and 45.4% (n=10) of the 22 subjects with HBV, in whom genotypes were tested. Eight (0.8%) subjects were positive for anti-HCV. Positive anti-HCV results were the highest in subjects from Central Asia (7.9%, n=3). CONCLUSION: Testing for hepatitis viral marker (hepatitis A virus IgG and HBsAg/anti-HBs) is needed for female marriage immigrants. Especially, HBV genotype B is different from genotype C of Koreans. Therefore, interest and attention to vaccination programs for female marriage immigrants are necessary for both clinicians and public health institutes.
Academies and Institutes
;
Asia
;
Asia, Southeastern
;
Biomarkers
;
Cambodia
;
China
;
Emigrants and Immigrants*
;
Female*
;
Genotype*
;
Hepatitis A
;
Hepatitis B Surface Antigens
;
Hepatitis B virus
;
Hepatitis B*
;
Hepatitis Viruses*
;
Hepatitis*
;
Humans
;
Immunoglobulin G
;
Japan
;
Korea*
;
Marriage*
;
Mass Screening
;
Philippines
;
Prevalence
;
Public Health
;
Seroepidemiologic Studies
;
Vaccination
;
Vietnam
8.Multiple Human Papillomavirus Infection Is Associated with High-Risk Infection in Male Genital Warts in Ulsan, Korea.
Taekmin KWON ; Kyung Hyun MOON ; Sung Hak YANG ; Min Cheol ROH ; Sang Hoon LEE ; Je Won KIM ; In Kyu KIM ; Kyoung Ho ROH ; Sungchan PARK
Journal of Korean Medical Science 2016;31(3):371-375
Further understanding of male human papillomavirus (HPV) infection is necessary to prevent infection in men, as well as transmission to women. In our current study, we investigated patterns of HPV infection and genotype distributions in male genital warts using the Anyplex II HPV28 Detection kit. We reviewed the medical records of 80 male patients who presented to 5 neighborhood clinics in Ulsan, Korea, for the treatment of genital warts between April 2014 and January 2015. All patients underwent HPV genotyping. The prevalence and characteristics of HPV infection were analyzed, and the patterns of HPV infection according to age were assessed. Among the study patients, 13 (16.3%) were negative for HPV infection, 46 (57.3%) were infected with low-risk HPV, and 21 (26.3%) were infected with high-risk HPV. Patients with multiple HPV infection were more likely to have high-risk HPV infection (P = 0.001). The prevalence of HPV infection was much higher in samples obtained by tissue excision due to a definite lesion (P = 0.001). There were no differences in high-risk HPV infection (P = 0.459), multiple HPV infection (P = 0.185), and recurrence at diagnosis (P = 0.178) according to age. HPV-6 and HPV-11 were the most common type overall (39.7% and 13.8%, respectively). HPV-16 and HPV-18 were the most common high-risk infections (both 3.4%). HPV infection is not only commonly encountered in male genital warts, but is also accompanied by high-risk HPV and multiple infections.
Adult
;
Condylomata Acuminata/epidemiology/*pathology/virology
;
DNA, Viral/genetics/metabolism
;
Genotype
;
Human papillomavirus 11/*genetics/isolation & purification
;
Human papillomavirus 16/genetics/isolation & purification
;
Human papillomavirus 18/genetics/isolation & purification
;
Human papillomavirus 6/*genetics/isolation & purification
;
Humans
;
Male
;
Middle Aged
;
Prevalence
;
Real-Time Polymerase Chain Reaction
;
Republic of Korea/epidemiology
;
Retrospective Studies
;
Risk Factors
9.The Variation of Choroidal Thickness and Refractive Error after Cataract Surgery.
Hyun Cheol ROH ; Choul Yong PARK ; Jong Hyun OH
Journal of the Korean Ophthalmological Society 2016;57(6):924-929
PURPOSE: To evaluate the effect of cataract surgery on subfoveal choroidal thickness (SCT) and investigate the relationship between the variation of SCT and refractive error. METHODS: We retrospectively reviewed the medical records of 47 patients (47 eyes) who underwent uneventful phacoemulsification cataract surgery from March 2012 to February 2014. SCTs were measured using spectral-domain optical coherence tomography performed before surgery and at 1 month, 3 months and 6 months postoperatively. We investigated the differences in target refraction (TR) and postoperative spherical equivalent (SE), intraocular pressure (IOP) and central macular thickness (CMT) at all follow-ups. RESULTS: Compared with preoperative measurements, SCT showed a significant increase of 5.9 ± 13.3 µm at postoperative 1 month and 7.6 ± 18.1 µm at postoperative 3 months (p = 0.004 and p = 0.006, respectively), but no significant differences at postoperative 6 months (p = 0.104). The correlation between the variation of SCT and the differences in postoperative SE and TR were not significant at 1 month and 6 months, but were positively significant at 3 months (r = 0.310, p = 0.034). The variation of SCT showed no significant correlations with the postoperative change in IOP and CMT. CONCLUSIONS: SCT significantly increased up to 3 months after cataract surgery. The variation of SCT may affect the postoperative refractive error.
Cataract*
;
Choroid*
;
Follow-Up Studies
;
Humans
;
Intraocular Pressure
;
Medical Records
;
Phacoemulsification
;
Refractive Errors*
;
Retrospective Studies
;
Tomography, Optical Coherence
10.A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats.
Hyoung Yun HAN ; Young Su YANG ; Soo Nam KIM ; Su Cheol HAN ; Kang Hyun HAN ; Jong Hwa LEE ; Ja Young JEONG ; Hang sik ROH ; Ji Hyeon SEOK ; Jeong Ah KIM ; Byung Sun MIN
Natural Product Sciences 2015;21(1):34-41
The objective of this study is to characterize a toxicity of Epimedii Herba (EH) in F344 rats and to find a dose levels for the 13 weeks toxicity study. EH is well known as medicinal herb in many Asian countries for traditional medicines of antibacterial and antiviral effects, estrogenic and antiestrogenic effects, and for treatment of osteoporosis, hypotensives, fatigue, kidney disorders, and related complications. However, the indispensable and basic information of toxicological evaluation of EH extract is insufficient to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and MFDS guideline in this study. The extract of EH was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed of 5 male and female rats. In this study, there were no treatment of EH-related adverse changes in clinical observations, mortality, body weights, food consumption, urinalysis, gross finding at necropsy, and organ weight examination. Total red blood cell count, hematocrit, mean corpuscular hemoglobin concentration, total cholesterol, and phospholipid were decreased in males and females at 5000 mg/kg/day compared to the control animals. Mean corpuscular volume and reticulocyte counts were increased in males and females at 5000 mg/kg/day compared to control animals. Therefore, we recommend that dose level of 5000 mg/kg/day is a highest treatment group in 13-week EH extract exposure study for further toxicity assessment.
Animals
;
Asian Continental Ancestry Group
;
Berberidaceae
;
Body Weight
;
Cholesterol
;
Compliance
;
Erythrocyte Count
;
Erythrocyte Indices
;
Estrogen Receptor Modulators
;
Estrogens
;
Fatigue
;
Female
;
Hematocrit
;
Humans
;
Kidney
;
Male
;
Mortality
;
Organ Size
;
Osteoporosis
;
Plants, Medicinal
;
Rats
;
Rats, Inbred F344*
;
Reticulocyte Count
;
Toxicity Tests
;
Urinalysis

Result Analysis
Print
Save
E-mail