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.Fracture Liaison Service in Korea: 2022 Position Statement of the Korean Society for Bone and Mineral Research
Jae-Young LIM ; Young Yul KIM ; Jin-Woo KIM ; Seongbin HONG ; Kyunghoon MIN ; Jaewon BEOM ; Byung-Ho YOON ; Sang Yoon LEE ; Sung Hye KONG ; Jun-Il YOO ; Myung Sook PARK ; Jae-Hwi NHO ; Sangbong KO ; Min Wook JOO ; Dong Hwan KIM ; Chan Ho PARK ; Tae-Young KIM ; Seil SOHN ; So Young PARK ; A Ram HONG ; Young Joo KWON ; Sung Bae PARK ; Young-Kyun LEE ; Nam Hoon MOON ; Bo Ryun KIM ; Yongsoon PARK ; Yonghan CHA ; Yong-Chan HA
Journal of Bone Metabolism 2023;30(1):31-36
Osteoporosis and osteoporotic fractures cause socioeconomic concerns, and medical system and policies appear insufficient to prepare for these issues in Korea, where the older adult population is rapidly increasing. Many countries around the world are already responding to osteoporosis and osteoporotic fractures by adopting fracture liaison service (FLS), and such an attempt has only begun in Korea. In this article, we introduce the operation methods for institutions implementing FLS and characteristics of services, and activities of the FLS Committee for FLS implementation in the Korean Society for Bone and Mineral Research. In addition, we hope that the current position statement will contribute to the implementation of FLS in Korea and impel policy changes to enable a multidisciplinary and integrated FLS operated under the medical system.
5.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.
6.Is the Mixed Use of Magnetic Resonance Enterography and Computed Tomography Enterography Adequate for Routine Periodic Follow-Up of Bowel Inflammation in Patients with Crohn’s Disease?
Jiyeon HA ; Seong Ho PARK ; Jung Hee SON ; Ji Hun KANG ; Byong Duk YE ; So Hyun PARK ; Bohyun KIM ; Sang Hyun CHOI ; Sang Hyoung PARK ; Suk-Kyun YANG
Korean Journal of Radiology 2022;23(1):30-41
Objective:
Computed tomography enterography (CTE) and magnetic resonance enterography (MRE) are considered substitutes for each other for evaluating Crohn’s disease (CD). However, the adequacy of mixing them for routine periodic follow-up for CD has not been established. This study aimed to compare MRE alone with the mixed use of CTE and MRE for the periodic follow-up of small bowel inflammation in patients with CD.
Materials and Methods:
We retrospectively compared two non-randomized groups, each comprising 96 patients with CD. One group underwent CTE and MRE (MRE followed by CTE or vice versa) for the follow-up of CD (interval, 13–27 months [median, 22 months]), and the other group underwent MRE alone (interval, 15–26 months [median, 21 months]). However, these two groups were similar in clinical characteristics. Three independent readers from three different institutions determined whether inflammation had decreased, remained unchanged, or increased within the entire small bowel and the terminal ileum based on sequential enterography of the patients after appropriate blinding. We compared the two groups for inter-reader agreement and accuracy (terminal ileum only) using endoscopy as the reference standard for enterographic interpretation.
Results:
The inter-reader agreement was greater in the MRE alone group for the entire small bowel (intraclass correlation coefficient [ICC]: 0.683 vs. 0.473; p = 0.005) and the terminal ileum (ICC: 0.656 vs. 0.490; p = 0.030). The interpretation accuracy was higher in the MRE alone group without statistical significance (70.9%–74.5% vs. 57.9%–64.9% in individual readers; adjusted odds ratio = 3.21; p = 0.077).
Conclusion
The mixed use of CTE and MRE was inferior to MRE alone in terms of inter-reader reliability and could probably be less accurate than MRE alone for routine monitoring of small bowel inflammation in patients with CD. Therefore, the consistent use of MRE is favored for this purpose.
7.Operational Definition Identifying Osteoporotic Vertebral Fractures in the Claims Database
Min Heui YU ; Namki HONG ; Seunghyun LEE ; Ha-Young KIM ; Hye-Sun PARK ; Sang-Min PARK ; Young-Kyun LEE ; Tae-Young KIM ; Yong-Chan HA ; Yumie RHEE ; Kyung-Hoi KOO
Journal of Korean Medical Science 2022;37(32):e249-
Background:
We analyzed the International Classification of Diseases, 10th edition (ICD-10) diagnostic codes, procedure codes, and radiographic image codes for vertebral fracture (VF) used in the database of Health Insurance Review and Assessment Service (HIRA) of Korea to establish a validated operational definition for identifying patients with osteoporotic VF in claims data.
Methods:
We developed three operational definitions for detecting VFs using 9 diagnostic codes, 5 procedure codes and 4 imaging codes. Medical records and radiographs of 2,819 patients, who had primary and subordinated codes of VF between January 2016 and December 2016 at two institutions, were reviewed to detect true vertebral fractures. We evaluated the sensitivity and positive predictive value (PPV) of the operational definition in detecting true osteoporotic VF and obtained the receiver operating characteristic (ROC) curve.
Results:
Among the 2,819 patients who had primary or secondary diagnosis codes for VF, 995 patients satisfied at least one of the criteria for the operational definition of osteoporotic VF. Of these patients, 594 were judged as having true fractures based on medical records and radiographic examinations. The sensitivity and PPV were 62.5 (95% confidence interval [CI], 59.4–65.6) and 59.7(95% CI, 56.6–62.8) respectively. In the receiver operating characteristic analysis, area under the curve (AUC) was 0.706 (95% CI, 0.688–0.724).
Conclusion
Our findings demonstrate the validity of our operational definitions to identify VFs more accurately using claims data. This algorithm to identify VF is likely to be useful in future studies for diagnosing osteoporotic VF.
8.Is Restoration of Hip Center Mandatory for Total Hip Arthroplasty of Protrusio Acetabuli?
Beom Seok LEE ; Hong Seok KIM ; O Sang KWON ; Young-Kyun LEE ; Yong-Chan HA ; Kyung-Hoi KOO
Hip & Pelvis 2022;34(2):106-114
Purpose:
While initial fixation using a press-fit of the acetabular cup is critical for the durability of the component, restoration of the hip center is regarded as an attributable factor for implant survival and successful outcome. In protrusio acetabuli (PA), obtaining both restoration of the hip center and the press-fit of the acetabular cup simultaneously might be difficult during total hip arthroplasty (THA). We tested the hypothesis that use of a medialized cup, if press-fitted, will not result in compromise of the implant stability and outcome after cementless THA of PA.
Materials and Methods:
A total of 26 cementless THAs of 22 patients with PA were reviewed. During THA, press-fit of the cup was prioritized rather than hip center restoration. A press-fit was obtained in 24 hips. A pressfit could not be obtained in the two remaining hips; therefore, reinforcement acetabular components were used.Restoration of the hip center was achieved in 17 cups; 15 primary cups and two reinforcement components; it was medialized in nine cups. Implant stability and modified Harris hip score (mHHS) between the two groups were compared at a mean follow-up of 5.1 years (range, 2-16 years).
Results:
Twenty-six cups; 17 restored cups and nine medialized press-fitted cups, remained stable at the latest follow-up. A similar final mHHS was observed between the restored group and the medialized group (83.6± 12.1 vs 83.8±10.4, P=0.786).
Conclusion
Implant stability and favorable results were obtained by press-fitted cups, irrespective of hip center restoration. THA in PA patients showed promising clinical and radiological results.
9.Comparison of Factors Associated With Direct Versus Transferred-in Admission to Government-Designated Regional Centers Between Acute Ischemic Stroke and Myocardial Infarction in Korea
Dae-Hyun KIM ; Seok-Joo MOON ; Juneyoung LEE ; Jae-Kwan CHA ; Moo Hyun KIM ; Jong-Sung PARK ; Byeolnim BAN ; Jihoon KANG ; Beom Joon KIM ; Won-Seok KIM ; Chang-Hwan YOON ; Heeyoung LEE ; Seongheon KIM ; Eun Kyoung KANG ; Ae-Young HER ; Cindy W YOON ; Joung-Ho RHA ; Seong-Ill WOO ; Won Kyung LEE ; Han-Young JUNG ; Jang Hoon LEE ; Hun Sik PARK ; Yang-Ha HWANG ; Keonyeop KIM ; Rock Bum KIM ; Nack-Cheon CHOI ; Jinyong HWANG ; Hyun-Woong PARK ; Ki Soo PARK ; SangHak YI ; Jae Young CHO ; Nam-Ho KIM ; Kang-Ho CHOI ; Juhan KIM ; Jae-Young HAN ; Jay Chol CHOI ; Song-Yi KIM ; Joon-Hyouk CHOI ; Jei KIM ; Min Kyun SOHN ; Si Wan CHOI ; Dong-Ick SHIN ; Sang Yeub LEE ; Jang-Whan BAE ; Kun Sei LEE ; Hee-Joon BAE
Journal of Korean Medical Science 2022;37(42):e305-
Background:
There has been no comparison of the determinants of admission route between acute ischemic stroke (AIS) and acute myocardial infarction (AMI). We examined whether factors associated with direct versus transferred-in admission to regional cardiocerebrovascular centers (RCVCs) differed between AIS and AMI.
Methods:
Using a nationwide RCVC registry, we identified consecutive patients presenting with AMI and AIS between July 2016 and December 2018. We explored factors associated with direct admission to RCVCs in patients with AIS and AMI and examined whether those associations differed between AIS and AMI, including interaction terms between each factor and disease type in multivariable models. To explore the influence of emergency medical service (EMS) paramedics on hospital selection, stratified analyses according to use of EMS were also performed.
Results:
Among the 17,897 and 8,927 AIS and AMI patients, 66.6% and 48.2% were directly admitted to RCVCs, respectively. Multivariable analysis showed that previous coronary heart disease, prehospital awareness, higher education level, and EMS use increased the odds of direct admission to RCVCs, but the odds ratio (OR) was different between AIS and AMI (for the first 3 factors, AMI > AIS; for EMS use, AMI < AIS). EMS use was the single most important factor for both AIS and AMI (OR, 4.72 vs. 3.90). Hypertension and hyperlipidemia increased, while living alone decreased the odds of direct admission only in AMI;additionally, age (65–74 years), previous stroke, and presentation during non-working hours increased the odds only in AIS. EMS use weakened the associations between direct admission and most factors in both AIS and AMI.
Conclusions
Various patient factors were differentially associated with direct admission to RCVCs between AIS and AMI. Public education for symptom awareness and use of EMS is essential in optimizing the transportation and hospitalization of patients with AMI and AIS.
10.Surgical importance of the posterior auricular ligament when harvesting ear cartilage in rhinoplasty
Daekwan CHI ; Seokui LEE ; Jae-Hee KIM ; Taek-Kyun KIM ; Jae-Yong JEONG ; Sunje KIM ; Sang-Ha OH
Archives of Aesthetic Plastic Surgery 2021;27(1):12-17
Background:
Ear cartilage is a preferred graft material in rhinoplasty. However, after harvest, instability of the auricular framework may arise as a form of donor site morbidity. In the harvest of ear cartilage, the posterior auricular ligament (PAL) is usually sacrificed in order to obtain as much cartilage as possible. Since damage to the PAL may cause auricular instability, we studied the periauricular anatomy using cadavers and evaluated auricular stability during surgery.
Methods:
Six ears from hemifacial cadavers were studied to clarify the exact anatomy of the PAL. Then, the recoil force of the auricle was serially measured to evaluate the stability of the auricular framework in 30 patients during surgery: before making the skin incision (M1), before and after cutting the PAL (M2, M3), and after harvesting the cymba concha (M4). The differences in force observed after cutting the PAL (ΔM2–M3) and after harvesting the cymba concha (ΔM3–M4) were statistically analyzed.
Results:
In the cadaveric study, the PAL was identified between the superficial and deep mastoid fasciae and connected the caudal aspect of the cymba concha to the deep mastoid fascia. During surgery, the PAL accounted for 16.20% of the total auricular recoil force. The recoil force decreased by 13.61 N and 11.25 N after cutting the PAL and harvesting the cymba concha, respectively. These decreases were statistically significant (P<0.05).
Conclusions
The results suggest that the PAL is a supporting structure of the auricle. Therefore, to preserve auricular stability, minimizing damage to the PAL while harvesting the ear cartilage may be helpful.

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