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.Impact of transient decrease in mixed venous oxygen saturation on prognosis in off-pump coronary artery bypass surgery: a retrospective cohort study
Kyuho LEE ; Kwang-Sub KIM ; Jong-Kwang PARK ; Jun Hyug CHOI ; Young-Lan KWAK ; Jae-Kwang SHIM
Korean Journal of Anesthesiology 2023;76(2):107-115
Background:
The prognostic consequences of transient hemodynamic deterioration due to cardiac displacement, which is most severe during left circumflex artery (LCX) grafting in off-pump coronary artery bypass surgery (OPCAB) are unknown. This study aimed to investigate the association between mixed venous oxygen saturation (SvO2) < 60% during LCX grafting and the occurrence of composite of morbidity endpoints.
Methods:
Data of patients who underwent elective OPCAB between January 2010 and December 2019 were reviewed. Logistic regression analysis was performed to detect risk factors for the composite of morbidity endpoints, defined as 30-day or in-hospital mortality, postoperative myocardial infarction, prolonged mechanical ventilation > 24 h, cerebrovascular accident, and acute kidney injury.
Results:
Among 1,071 patients, the composite of morbidity endpoints occurred in 303 (28%) patients. SvO2 < 60% during LCX grafting was significantly associated with the composite of morbidity (OR: 2.72, 95% CI [1.60, 4.61], P < 0.001) along with advanced age, chronic kidney disease, ratio of early mitral inflow velocity to mitral annular early diastolic velocity, and EuroSCORE II. Other major hemodynamic variables including the cardiac index were not associated with the outcome. Additional regression analysis revealed pre-operative anemia as a predictor of SvO2 < 60% during LCX grafting (OR: 2.09, 95% CI [1.33, 3.29], P = 0.001).
Conclusions
A decrease in SvO2 < 60%, albeit confined to the period of cardiac displacement, was associated with a 2.7-fold increased risk of detrimental outcomes after OPCAB, implying the prognostic importance of this transient deterioration in oxygen supply-demand balance.
5.Hemodynamic management during off-pump coronary artery bypass surgery: a narrative review of proper targets for safe execution and troubleshooting
Jae-Kwang SHIM ; Kwang-Sub KIM ; Pierre COUTURE ; André DENAULT ; Young-Lan KWAK ; Kyung-Jong YOO ; Young-Nam YOUN
Korean Journal of Anesthesiology 2023;76(4):267-279
Off-pump coronary surgery requires mechanical cardiac displacement, which results in bi-ventricular systolic and diastolic dysfunction. Although transient, subsequent hemodynamic deterioration can be associated with poor prognosis and, in extreme cases, emergency conversion to on-pump surgery, which is associated with high morbidity and mortality. Thus, appropriate decision-making regarding whether the surgery can be proceeded based on objective hemodynamic targets is essential before coronary arteriotomy. For adequate hemodynamic management, avoiding myocardial oxygen supply-demand imbalance, which includes maintaining mean arterial pressure above 70 mmHg and preventing an increase in oxygen demand beyond the patient’s coronary reserve, must be prioritized. Maintaining mixed venous oxygen saturation above 60%, which reflects the lower limit of adequate global oxygen supply-demand balance, is also essential. Above all, severe mechanical cardiac displacement incurring compressive syndromes, which cannot be overcome by adjusting major determinants of cardiac output, should be avoided. An uncompromising form of cardiac constraint can be ruled out as long as the central venous pressure is not equal to or greater than the pulmonary artery diastolic (or occlusion) pressure, as this would reflect tamponade physiology. In addition, transesophageal echocardiography should be conducted to rule out mechanical cardiac displacement-induced ventricular interdependence, dyskinesia, severe mitral regurgitation, and left ventricular outflow tract obstruction with or without systolic motion of the anterior leaflet of the mitral valve, which cannot be tolerated during grafting. Finally, the ascending aorta should be carefully inspected for gas bubbles to prevent hemodynamic collapse caused by a massive gas embolism obstructing the right coronary ostium.
6.Effects of Progressive Core and Ankle Muscle Strengthening Exercises Using Thera-Band on Body Balance
Kwang-Sub LEE ; Ji-Won WANG ; Dong Yeop LEE ; Jae Ho YU ; Jin Seop KIM ; Seung Gil KIM ; Ji heon HONG
Journal of Korean Physical Therapy 2022;34(3):121-127
Purpose:
This study aims to compare the effect on balance during core and ankle muscle strengthening exercises using the Thera-Band.
Methods:
21 healthy college students were recruited. The participants were divided into a core strengthening group (CSG), an ankle strengthening group (ASG), and a non-exercise group (NEG). CSG and ASG were performed twice a week for a total of 4 weeks, and static and dynamic balance were measured before and after the intervention. The static balance were measured as stability index and weight distribution index using Tetrax®. The dynamic balance was measured in each direction by the Y balance test. The Thera-Band intensity was increased after 2 weeks of exercise, and the exercise was subsequently performed.
Results:
Participants showed static balance with Tetrax®, a significant difference was noted between normal eye closes and pillow with eye closes in ASG (p < 0.05). In the case of dynamic balance with the Y balance test, a significant difference was observed in posterolateral direction (PL) and composite score (CS) between each group for the pre- and post-intervention differences (p < 0.05). A significant difference was observed between PL and CS in CSG (p < 0.05).
Conclusion
These findings show that the progressive Thera-Band exercise had a positive effect on balance abilities. It was confirmed that core strengthening was effective for dynamic balance, and ankle strengthening was effective for static balance.
7.Delays in Intracerebral Hemorrhage Management Is Associated with Hematoma Expansion and Worse Outcomes: Changes in COVID-19 Era
Hyun Jin HAN ; Keun Young PARK ; Junhyung KIM ; Woosung LEE ; Yun Ho LEE ; Chang Ki JANG ; Kwang-Chun CHO ; Sang Kyu PARK ; Joonho CHUNG ; Young Sub KWON ; Yong Bae KIM ; Jae Whan LEE ; So Yeon KIM
Yonsei Medical Journal 2021;62(10):911-917
Purpose:
The coronavirus disease 2019 (COVID-19) pandemic disrupted the emergency medical care system worldwide. We analyzed the changes in the management of intracerebral hemorrhage (ICH) and compared the pre-COVID-19 and COVID-19 eras.
Materials and Methods:
From March to October of the COVID-19 era (2020), 83 consecutive patients with ICH were admitted to four comprehensive stroke centers. We retrospectively reviewed the data of patients and compared the treatment workflow metrics, treatment modalities, and clinical outcomes with the patients admitted during the same period of pre-COVID-19 era (2017–2019).
Results:
Three hundred thirty-eight patients (83 in COVID-19 era and 255 in pre-COVID-19 era) were included in this study. Symptom onset/detection-to-door time [COVID-19; 56.0 min (34.0–106.0), pre-COVID-19; 40.0 min (27.0–98.0), p=0.016] and median door to-intensive treatment time differed between the two groups [COVID-19; 349.0 min (177.0–560.0), pre-COVID-19; 184.0 min (134.0–271.0), p<0.001]. Hematoma expansion was detected more significantly in the COVID-19 era (39.8% vs. 22.1%, p=0.002). At 3-month follow-up, clinical outcomes of patients were worse in the COVID-19 era (Good modified Rankin Scale; 33.7% in COVID-19, 46.7% in pre-COVID-19, p=0.039).
Conclusion
During the COVID-19 era, delays in management of ICH was associated with hematoma expansion and worse outcomes.
8.Delays in Intracerebral Hemorrhage Management Is Associated with Hematoma Expansion and Worse Outcomes: Changes in COVID-19 Era
Hyun Jin HAN ; Keun Young PARK ; Junhyung KIM ; Woosung LEE ; Yun Ho LEE ; Chang Ki JANG ; Kwang-Chun CHO ; Sang Kyu PARK ; Joonho CHUNG ; Young Sub KWON ; Yong Bae KIM ; Jae Whan LEE ; So Yeon KIM
Yonsei Medical Journal 2021;62(10):911-917
Purpose:
The coronavirus disease 2019 (COVID-19) pandemic disrupted the emergency medical care system worldwide. We analyzed the changes in the management of intracerebral hemorrhage (ICH) and compared the pre-COVID-19 and COVID-19 eras.
Materials and Methods:
From March to October of the COVID-19 era (2020), 83 consecutive patients with ICH were admitted to four comprehensive stroke centers. We retrospectively reviewed the data of patients and compared the treatment workflow metrics, treatment modalities, and clinical outcomes with the patients admitted during the same period of pre-COVID-19 era (2017–2019).
Results:
Three hundred thirty-eight patients (83 in COVID-19 era and 255 in pre-COVID-19 era) were included in this study. Symptom onset/detection-to-door time [COVID-19; 56.0 min (34.0–106.0), pre-COVID-19; 40.0 min (27.0–98.0), p=0.016] and median door to-intensive treatment time differed between the two groups [COVID-19; 349.0 min (177.0–560.0), pre-COVID-19; 184.0 min (134.0–271.0), p<0.001]. Hematoma expansion was detected more significantly in the COVID-19 era (39.8% vs. 22.1%, p=0.002). At 3-month follow-up, clinical outcomes of patients were worse in the COVID-19 era (Good modified Rankin Scale; 33.7% in COVID-19, 46.7% in pre-COVID-19, p=0.039).
Conclusion
During the COVID-19 era, delays in management of ICH was associated with hematoma expansion and worse outcomes.
9.Comparison of the Efficacy between First-Line Treatment Regimens for Patients with Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer
Kwang Hyun CHOI ; Chan Sub PARK ; Sang Hee KIM ; Na Won KIM ; Ju Hyeon LEE ; Ji Yea KIM ; In Chul PARK ; Min Ki SEONG ; Hyun-Ah KIM ; Woo Chul NOH
Journal of Breast Disease 2021;9(2):65-70
Purpose:
Endocrine therapy is the first-line treatment recommended for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer without visceral crisis. However, this recommendation has not been followed clinically because of efficacy issues. In this study, the survival of patients with HR-positive/HER2-negative metastatic breast cancer was evaluated based on the following first-line treatment regimens: the combination of palbociclib plus letrozole, conventional endocrine therapy, or chemotherapy.
Methods:
Medical records were reviewed for this retrospective analysis. Patients with HR-positive/HER2-negative metastatic breast cancer were included. Progression-free survival (PFS) and overall survival (OS) were compared based on first-line treatment regimens.
Results:
A total of 184 patients were included in the analysis. The first-line treatments were palbociclib plus letrozole in 46 patients (25.0%), endocrine therapy in 40 patients (21.7%), and chemotherapy in 98 patients (53.3%). The PFS of the palbociclib plus letrozole group was significantly longer than that of the endocrine therapy (hazard ratio=3.43, p<0.001) and chemotherapy (hazard ratio=2.88, p=0.001) groups. No significant difference was observed between the endocrine therapy and chemotherapy groups (p=0.430). The OS of the palbociclib plus letrozole group was significantly longer than that of the endocrine therapy (hazard ratio=5.34, p=0.009) and chemotherapy (hazard ratio 4.23, p=0.043) groups. No significant difference was observed between the endocrine therapy and chemotherapy groups (p=0.451).
Conclusion
The combination regimen of palbociclib and letrozole could be recommended as the first-line treatment of choice in patients with HR-positive/HER2-negative metastatic breast cancer.
10.Perioperative management of patients receiving non-vitamin K antagonist oral anticoagulants: up-to-date recommendations
Kwang-Sub KIM ; Jong Wook SONG ; Sarah SOH ; Young-Lan KWAK ; Jae-Kwang SHIM
Anesthesia and Pain Medicine 2020;15(2):133-142
Indications of non-vitamin K antagonist oral anticoagulants (NOACs), consisting of two types: direct thrombin inhibitor (dabigatran) and direct factor Xa inhibitor (rivaroxaban, apixaban, and edoxaban), have expanded over the last few years. Accordingly, increasing number of patients presenting for surgery are being exposed to NOACs, despite the fact that NOACs are inevitably related to increased perioperative bleeding risk. This review article contains recent clinical evidence-based up-to-date recommendations to help set up a multidisciplinary management strategy to provide a safe perioperative milieu for patients receiving NOACs. In brief, despite the paucity of related clinical evidence, several key recommendations can be drawn based on the emerging clinical evidence, expert consensus, and predictable pharmacological properties of NOACs. In elective surgeries, it seems safe to perform high-bleeding risk surgeries 2 days after cessation of NOAC, regardless of the type of NOAC. Neuraxial anesthesia should be performed 3 days after cessation of NOACs. In both instances, dabigatran needs to be discontinued for an additional 1 or 2 days, depending on the decrease in renal function. NOACs do not require a preoperative heparin bridge therapy. Emergent or urgent surgeries should preferably be delayed for at least 12 h from the last NOAC intake (better if > 24 h). If surgery cannot be delayed, consider using specific reversal agents, which are idarucizumab for dabigatran and andexanet alfa for rivaroxaban, apixaban, and edoxaban. If these specific reversal agents are not available, consider using prothrombin complex concentrates.

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