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.Effectiveness and Usefulness of Bone Turnover Marker in Osteoporosis Patients: A Multicenter Study in Korea
Jun-Il YOO ; So Young PARK ; Deog-Yoon KIM ; Jeonghoon HA ; Yumie RHEE ; Namki HONG ; Jung-Taek KIM ; Hyon-Seung YI ; Bu Kyung KIM ; Young-Kyun LEE ; Yong-Chan HA ; Yun Kyung JEON ; Ha-Young KIM ; Seong Hee AHN ; Seongbin HONG ; Sang-Yeob LEE
Journal of Bone Metabolism 2023;30(4):311-317
Background:
This study aimed to investigate real-world data of C-terminal telopeptide (CTX), propeptide of type I collagen (P1NP), and osteocalcin through present multicenter clinical study, and retrospectively analyze the usefulness of bone turnover markers (BTMs) in Koreans.
Methods:
The study focused on pre- and post-menopausal patients diagnosed with osteoporosis and excluded patients without certain test results or with test intervals of over 1 year. The demographic data and 3 BTMs (CTX, P1NP, and osteocalcin) were collected. The patients were classified by demographic characteristics and the BTM concentrations were analyzed by the group.
Results:
Among women with no history of fractures, the levels of P1NP (N=2,100) were 43.544±36.902, CTX (N=1,855) were 0.373 ±0.927, and osteocalcin (N=219) were 10.81 ±20.631. Among men with no history of fractures, the levels of P1NP (N=221) were 48.498±52.892, CTX (N=201) were 0.370±0.351, and osteocalcin (N=15) were 7.868 ±10.674. Treatment with teriparatide increased the P1NP levels after 3 months in both men and women, with a 50% increase observed in women. Similarly, treatment with denosumab decreased the CTX levels after 3 months in both men and women, with a reduction of 50% observed in women.
Conclusions
The results of this study can contribute to the accurate assessment of bone replacement status in Koreans. We also provide the P1NP level in the Korean population for future comparative studies with other populations.
5.Erratum: Role of Intensive Inpatient Rehabilitation for Prevention of Disability after Stroke: The Korean Stroke Cohort for Functioning and Rehabilitation (KOSCO) Study
Won Hyuk CHANG ; Min Kyun SOHN ; Jongmin LEE ; Deog Young KIM ; Sam-Gyu LEE ; Yong-Il SHIN ; Gyung-Jae OH ; Yang-Soo LEE ; Min Cheol JOO ; Eun Young HAN ; Junhee HAN ; Yun-Hee KIM
Brain & Neurorehabilitation 2022;15(2):e22-
6.Comparison of sandblasted and acid-etched surface implants and new hydrophilic surface implants in the posterior maxilla using a 3-month early-loading protocol: a randomized controlled trial
Hyeong Gi KIM ; Pil-Young YUN ; Young-Kyun KIM ; Il-hyung KIM
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2021;47(3):175-182
Objectives:
In this prospective randomized controlled trial, we measured the primary and secondary stability of two surface-treated implants placed in the posterior maxilla, applied 3-month loading protocols, and compared and analyzed the short-term outcomes of the implants.
Patients and Methods:
From June 2018 to June 2019, patients with a residual bone height of 4 mm in the posterior maxilla were enrolled and randomly divided into two groups to place SA implants (Osstem Implants, Korea) in Group A and NH implants (Hiossen, USA) in Group B. Finally, 14 implants placed in 13 patients in Group A and 17 implants placed in 14 patients in Group B were analyzed. The measured primary and secondary stability of each implant was represented by implant stability quotient (ISQ), and treatment outcomes were evaluated.
Results:
Group A consisted of patients with an average age of 62.2 years (range, 48-80 years), and Group B consisted of patients with an average age of 58.1 years (range, 35-82 years). Primary stability was 73.86±6.40 and 71.24±5.32 in Groups A and B, respectively (P=0.222). Secondary stability was 79.07±5.21 in Group A and 78.29±4.74 in Group B (P=0.667). A steep increase in ISQ during the healing period was observed in Group B, though it was not significant (P=0.265). The mean follow-up period was 378.5±164.6 days in Group A and 385.3±167.9 days in Group B. All implants in each group met the success criteria, and the success rate was 100%.
Conclusion
Two surface-treated implants placed in the posterior maxilla with greater than 4 mm alveolar bone height exhibited successful one-year treatment outcomes if a primary stability of 65 or higher ISQ was obtained and a 3-month early loading protocol was applied.
7.Comparison of sandblasted and acid-etched surface implants and new hydrophilic surface implants in the posterior maxilla using a 3-month early-loading protocol: a randomized controlled trial
Hyeong Gi KIM ; Pil-Young YUN ; Young-Kyun KIM ; Il-hyung KIM
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2021;47(3):175-182
Objectives:
In this prospective randomized controlled trial, we measured the primary and secondary stability of two surface-treated implants placed in the posterior maxilla, applied 3-month loading protocols, and compared and analyzed the short-term outcomes of the implants.
Patients and Methods:
From June 2018 to June 2019, patients with a residual bone height of 4 mm in the posterior maxilla were enrolled and randomly divided into two groups to place SA implants (Osstem Implants, Korea) in Group A and NH implants (Hiossen, USA) in Group B. Finally, 14 implants placed in 13 patients in Group A and 17 implants placed in 14 patients in Group B were analyzed. The measured primary and secondary stability of each implant was represented by implant stability quotient (ISQ), and treatment outcomes were evaluated.
Results:
Group A consisted of patients with an average age of 62.2 years (range, 48-80 years), and Group B consisted of patients with an average age of 58.1 years (range, 35-82 years). Primary stability was 73.86±6.40 and 71.24±5.32 in Groups A and B, respectively (P=0.222). Secondary stability was 79.07±5.21 in Group A and 78.29±4.74 in Group B (P=0.667). A steep increase in ISQ during the healing period was observed in Group B, though it was not significant (P=0.265). The mean follow-up period was 378.5±164.6 days in Group A and 385.3±167.9 days in Group B. All implants in each group met the success criteria, and the success rate was 100%.
Conclusion
Two surface-treated implants placed in the posterior maxilla with greater than 4 mm alveolar bone height exhibited successful one-year treatment outcomes if a primary stability of 65 or higher ISQ was obtained and a 3-month early loading protocol was applied.
8.Post-stroke Hyperglycemia in Non-diabetic Ischemic Stroke is Related With Worse Functional Outcome: A Cohort Study
Jin A YOON ; Yong-Il SHIN ; Deog Young KIM ; Min Kyun SOHN ; Jongmin LEE ; Sam-Gyu LEE ; Yang-Soo LEE ; Eun Young HAN ; Min Cheol JOO ; Gyung-Jae OH ; Minsu PARK ; Won Hyuk CHANG ; Yun-Hee KIM
Annals of Rehabilitation Medicine 2021;45(5):359-367
Objective:
To investigate long-term and serial functional outcomes in ischemic stroke patients without diabetes with post-stroke hyperglycemia.
Methods:
The Korean Stroke Cohort for Functioning and Rehabilitation (KOSCO) is a large, multi-center, prospective cohort study of stroke patients admitted to participating hospitals in nine areas of Korea. From KOSCO, ischemic stroke patients without diabetes were recruited and divided into two groups: patients without diabetes without (n=779) and with post-stroke hyperglycemia (n=223). Post-stroke hyperglycemia was defined as a glucose level >8 mmol/L. Functional assessments were performed 7 days and 3, 6, and 12 months after stroke onset.
Results:
There were no significant differences in baseline characteristics between the groups, except in the age of onset and smoking. Analysis of the linear correlation between the initial National Institutes of Health Stroke Scale (NIHSS) score and glucose level showed no significant difference. Among our functional assessments, NIHSS, Fugl-Meyer Assessment (affected side), Functional Ambulatory Category, modified Rankin Scale, and Korean Mini-Mental State Examination (K-MMSE) showed statistically significant improvements in each group. All functional improvements except K-MMSE were significantly higher in patients without post-stroke hyperglycemia at 7 days and 3, 6, and 12 months.
Conclusion
The glucose level of ischemic stroke patients without diabetes had no significant correlation with the initial NIHSS score. The long-term effects of stress hyperglycemia showed worse functional outcomes in ischemic stroke patients without diabetes with post-stroke hyperglycemia.
9.Factors Associated to Returning Home in the First Year after Stroke
Seung Han KIM ; Yong Il SHIN ; Seung Chan KIM ; Sung Hwa KO ; Deog Young KIM ; Jongmin LEE ; Min Kyun SOHN ; Sam Gyu LEE ; Gyung Jae OH ; Yang Soo LEE ; Min Cheol JOO ; Eun Young HAN ; Junhee HAN ; Won Hyuk CHANG ; Ji Hong MIN ; Yun Hee KIM
Brain & Neurorehabilitation 2020;13(1):1-
The objective of this study was to investigate factors affecting the return home one year after a stroke. The subjects of this study consisted of patients who participated in a large-scale multi-objective cohort study of initial stage stroke patients who were admitted to 9 representative hospitals in Korea. We analyzed the distribution of the subjects who had experienced stroke a year earlier by distinguishing the group who returned home and the other group that was hospitalized in rehabilitation hospitals. Based on this distribution, we evaluated the demographic, environmental, clinical, and psychological factors that can affect the return home. Overall, there were 464 subjects in the ‘Return home’ group and 99 subjects in the ‘Rehabilitation hospitalization’ group. job status, inconvenient housing structures, residential types, diagnosis, Functional Ambulation Categories, modified Rankin Scale, Korea-Modified Barthel Index, Function Independence Measure, Fugl-Meyer Assessment, Korean version of Mini-Mental State Examination, Korean version of Frenchay Aphasia Screening Test, Psychosocial Well-being Index-Short Form, Geriatric Depression Scale-Short Form, EuroQol-five Dimensional showed a significant difference between the 2 groups one year after the stroke. The factors affecting the return home one year after a stroke include functional status, activities of daily living, cognition, depression, stress, quality of life, job status. It is expected that factors affecting the rehabilitation of patients with stroke can be considered as basic data for establishing rehabilitation goals and treatment plans.
Activities of Daily Living
;
Aphasia
;
Cognition
;
Cohort Studies
;
Depression
;
Diagnosis
;
Housing
;
Humans
;
Korea
;
Mass Screening
;
Patient Discharge
;
Psychology
;
Quality of Life
;
Rehabilitation
;
Stroke
;
Walking
10.Factors Associated to Returning Home in the First Year after Stroke
Seung Han KIM ; Yong Il SHIN ; Seung Chan KIM ; Sung Hwa KO ; Deog Young KIM ; Jongmin LEE ; Min Kyun SOHN ; Sam Gyu LEE ; Gyung Jae OH ; Yang Soo LEE ; Min Cheol JOO ; Eun Young HAN ; Junhee HAN ; Won Hyuk CHANG ; Ji Hong MIN ; Yun Hee KIM
Brain & Neurorehabilitation 2020;13(1):e1-
The objective of this study was to investigate factors affecting the return home one year after a stroke. The subjects of this study consisted of patients who participated in a large-scale multi-objective cohort study of initial stage stroke patients who were admitted to 9 representative hospitals in Korea. We analyzed the distribution of the subjects who had experienced stroke a year earlier by distinguishing the group who returned home and the other group that was hospitalized in rehabilitation hospitals. Based on this distribution, we evaluated the demographic, environmental, clinical, and psychological factors that can affect the return home. Overall, there were 464 subjects in the ‘Return home’ group and 99 subjects in the ‘Rehabilitation hospitalization’ group. job status, inconvenient housing structures, residential types, diagnosis, Functional Ambulation Categories, modified Rankin Scale, Korea-Modified Barthel Index, Function Independence Measure, Fugl-Meyer Assessment, Korean version of Mini-Mental State Examination, Korean version of Frenchay Aphasia Screening Test, Psychosocial Well-being Index-Short Form, Geriatric Depression Scale-Short Form, EuroQol-five Dimensional showed a significant difference between the 2 groups one year after the stroke. The factors affecting the return home one year after a stroke include functional status, activities of daily living, cognition, depression, stress, quality of life, job status. It is expected that factors affecting the rehabilitation of patients with stroke can be considered as basic data for establishing rehabilitation goals and treatment plans.

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