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.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
5.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.
6.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.
7.Extraction socket sealing using palatal gingival grafts and resorbable collagen membranes.
Sang Yun KIM ; Young Kyun KIM ; Hyun Suk KIM ; Pil Young YUN ; Su Gwan KIM ; Yong Hun CHOI
Maxillofacial Plastic and Reconstructive Surgery 2017;39(12):39-
BACKGROUND: Socket sealing surgery is performed for the preservation of the form and volume of the soft tissue by covering the resulting socket with autogenous soft tissue graft or membrane barriers. This procedure is usually necessary to improve the esthetic results of the maxillary anterior or premolar areas. METHODS: This study retrospectively investigated cases involving the open membrane technique or socket sealing surgery with a palatal gingival graft or collagen membrane where implant placement and bone grafting were performed immediately after tooth extraction. From January 2005 to December 2008, socket sealing surgery was performed in 24 patients, and 25 implants were placed. RESULTS: All implants were successful in the follow-up period. In the palatal gingival graft group, the mean marginal bone loss was 1.17 mm during the mean follow-up period of 81.0 months. In the collagen membrane group, the mean marginal bone loss was 1.23 mm during the mean follow-up period of 76.9 months. There was no significant difference between the two groups. CONCLUSIONS: Consequently, socket sealing surgery is effective at minimizing the loss of soft tissue and alveolar bone.
Bicuspid
;
Bone Transplantation
;
Collagen*
;
Follow-Up Studies
;
Humans
;
Membranes*
;
Retrospective Studies
;
Tooth Extraction
;
Transplants*
8.Idiopathic hypereosinophilic syndrome presenting with urinary frequency, abdominal pain, and diarrhea.
Ja Kyung KIM ; Joo Hee KIM ; Han Min PARK ; Yong Seol JEONG ; Chung Jo CHOI ; Seong Kyun NA ; Jong Hyeok KIM ; Young Rim SONG ; Yong Il HWANG ; Seung Hun JANG ; Ki Suck JUNG
Allergy, Asthma & Respiratory Disease 2015;3(1):77-81
Idiopathic hypereosinophilic syndrome (IHES) is a rare disorder defined by persistent blood eosinophilia, evidence of eosinophil-associated organ dysfunction and absence of secondary causes. Eosinophilic infiltration and its mediator release can cause damage to multiple organs. Although IHES can involve every organ system, bladder involvement is rarely evidenced. We recently reported a case of IHES with both bladder and gastrointestinal tract involvement. A 43-year-old woman visited Hallym University Sacred Heart Hospital complaining of urinary frequency, abdominal pain, and diarrhea for several months. Abdominal pelvic computed tomographic scan showed diffuse wall thickenings in her bladder and colon with small pelvic ascites. Laboratory investigation showed a marked peripheral eosinophilia and tissue biopsies confirmed eosinophilic infiltration in the bladder wall, esophagus, and duodenum. The patient was treated with prednisolone and her eosinophilia and symptoms have gradually improved.
Abdominal Pain*
;
Adult
;
Ascites
;
Biopsy
;
Colon
;
Cystitis
;
Diarrhea*
;
Duodenum
;
Enteritis
;
Eosinophilia
;
Eosinophilic Esophagitis
;
Eosinophils
;
Esophagus
;
Female
;
Gastrointestinal Tract
;
Heart
;
Humans
;
Hypereosinophilic Syndrome*
;
Prednisolone
;
Urinary Bladder
9.Current Trends in the Assessment of Patients with Tinnitus and the Proposal of Tinnitus Assessment in Korea.
Jiwon CHANG ; Tae Su KIM ; Eui Cheol NAM ; In Seok MOON ; Moo Kyun PARK ; Shi Nae PARK ; Hun Yi PARK ; Jae Hyun SEO ; Yong Hwi AN ; Jeong Hun JANG ; June CHOI
Korean Journal of Otolaryngology - Head and Neck Surgery 2014;57(10):671-686
BACKGROUND AND OBJECTIVES: The effective management of tinnitus should start with an accurate diagnosis, but no concensus has been developed in Korea concerning how to measure the features of tinnitus. This study surveyed otologists in the training hospitals and hospitals specialized in otologic care in Korea to identify the current status in the assessment of patients with tinnitus. SUBJECTS AND METHOD: The questionnaire on the assessment of tinnitus was sent by email to otologists in training and to specialized hospitals specializing in otologics in Korea. The questionnaire included inquiry about various types of tests conducted, such as the audiologic test, tinnitus test, blood test, radiologic test, and the methods of history taking and physical examination for somatic tinnitus. RESULTS: Regarding the audiologic assessment of tinnitus, all the otologist were using pure tone audiometry, 97% speech audiometry, and 87% tinnitus test. For the psychophysical measure of tinnitus, both loudness and pitch matching were conducted by all the otologists. The performance rate of blood test were 38.5%, and the most preferred radiologic test in pulsatile tinnitus was temporal bone computed tomography (59%). Finally, the rate of investigation including the history taking and physical examination of somatic tinnitus was between 74-84%. CONCLUSION: Our results showed that although the tests perfermed by otologists varied, the essential tests for assessing tinnitus were commonly practiced. We analyzed the current status of tinnitus assessment and supplemented guidlines to help measure tinnitus. Further concensus on tinnitus diagnosis is needed, particularly about the standadized and unified principles.
Audiometry
;
Audiometry, Speech
;
Diagnosis
;
Electronic Mail
;
Hematologic Tests
;
Humans
;
Korea
;
Physical Examination
;
Surveys and Questionnaires
;
Temporal Bone
;
Tinnitus*
10.Abdominal Radiography for the Evaluation of Acute Fecal Impaction in Children in Pediatric Emergency Department: Comparison of Three Scoring Methods.
Jungho CHOI ; Young Ho KWAK ; Do Kyun KIM ; Jin Hee YI ; Jin Hee JEONG ; Hahn Bom KIM ; Jae Yun JUNG ; Dong Bum SUH ; Jung Eun CHEON ; Young Hun CHOI
Journal of the Korean Society of Emergency Medicine 2013;24(2):224-229
PURPOSE: The aim of this study is to evaluate suitable tools for an approach to acute fecal impaction by comparison of the Leech, Barr and Blethyn scoring methods in pediatric emergency department (PED). METHODS: Children with diagnosis of fecal impaction were included in this study at PED of Seoul National University Hospital. Of them, 50 children were randomly selected and their radiographs were independently scored on two occasions at two weeks intervals using three scoring methods by nine emergency physicians and one radiologist. Inter-observer and intra-observer agreement were assessed by calculating intra-class correlation coefficient (ICC). Likert scale was used to assess the easiness and effectiveness of Leech, Barr and Blethyn scoring methods. RESULTS: (I) Inter-observer agreement: The ICC values of the Leech, Barr and Blethyn were 0.861, 0.887, and 0.821 at first trial and 0.889, 0.891, and 0.827 at second trial, respectively (p<0.001 for all). (II) Intra-observer agreement: Among researchers, the numbers who showed very confident (ICC>0.8) were 5, 6 and 2 in Leech, Barr and Blethyn, respectively. (III) Easiness and effectiveness: The mean Likert scale of the Leech, Barr and Blethyn in easiness was 4.4, 1.4, and 3.9 and in effectiveness, 3.9, 2.9, and 3.2, respectively; it showed significant differences for both attributes (p<0.001, p=0.03, respectively). In post-hoc test, the Leech was assumed to be easier and more effective than Barr (p<0.001). However, no significant differences in easiness and effectiveness were observed between Leech and Blethyn (p=0.37, p=0.14, respectively). CONCLUSION: The Leech, Barr and Blethyn have all good inter-observer agreement. The Leech has been found to carry better intra-observer agreement than the other two, and may be one of the easiest and most effective tools for the evaluation of acute fecal impaction in children in PED.
Child
;
Emergencies
;
Fecal Impaction
;
Humans
;
Observer Variation
;
Radiography, Abdominal
;
Research Design

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