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.Insulin pump therapy in transient neonatal diabetes mellitus.
Joong Heum PARK ; Jeong Hee KANG ; Kyu Hyung LEE ; Nam Hyo KIM ; Han Wook YOO ; Dae Yeol LEE ; Eun Gyong YOO
Annals of Pediatric Endocrinology & Metabolism 2013;18(3):148-151
Neonatal diabetes mellitus (NDM) is a rare disease requiring insulin treatment. Its treatment is primarily focused on maintaining adequate glycemic control and avoiding hypoglycemia. Although insulin pump therapy is frequently administered to adults and children, there is no consensus on the use of insulin pumps in NDM. A 10 day-old female infant was referred to us with intrauterine growth retardation and poor weight gain. Hyperglycemia was noted, and continuous intravenous insulin infusion was initiated. However, the patient's serum glucose levels fluctuated widely, and maintaining the intravenous route became difficult within the following weeks. Continuous subcutaneous insulin infusion with an insulin pump was introduced on the twenty-fifth day of life, and good glycemic control was achieved without any notable adverse effects including hypoglycemia. We suggest that the insulin pump is a safe and effective mode for treating NDM and its early adoption may shorten the length of hospital stays in patients with NDM.
Blood Glucose
;
Diabetes Mellitus*
;
Female
;
Fetal Growth Retardation
;
Humans
;
Hyperglycemia
;
Hypoglycemia
;
Infant
;
Infant, Newborn
;
Insulin Infusion Systems*
;
Insulin
;
Length of Stay
;
Rare Diseases
;
Weight Gain
5.Correlation between the Severity of Obstructive Sleep Apnea and Heart Rate Variability Indices.
Doo Heum PARK ; Chul Jin SHIN ; Seok Chan HONG ; Jaehak YU ; Seung Ho RYU ; Eui Joong KIM ; Hong Beom SHIN ; Byoung Hak SHIN
Journal of Korean Medical Science 2008;23(2):226-231
The risk of cardiovascular disease is known to be increased in obstructive sleep apnea syndrome (OSAS). Its mechanism can be explained by the observation that the sympathetic tone increases due to repetitive apneas accompanied by hypoxias and arousals during sleep. Heart rate variability (HRV) representing cardiac autonomic function is mediated by respiratory sinus arrhythmia, baroreflexrelated fluctuation, and thermoregulation-related fluctuation. We evaluated the heart rate variability of OSAS patients during night to assess their relationship with the severity of the symptoms. We studied overnight polysomnographies of 59 male untreated OSAS patients with moderate to severe symptoms (mean age 45.4+/- 11.7 yr, apnea-hypopnea index [AHI]=43.2+/-23.4 events per hour, and AHI >15). Moderate (mean age 47.1+/-9.4 yr, AHI=15-30, n=22) and severe (mean age 44.5 +/-12.9 yr, AHI >30, n=37) OSAS patients were compared for the indices derived from time and frequency domain analysis of HRV, AHI, oxygen desaturation event index (ODI), arousal index (ArI), and sleep parameters. As a result, the severe OSAS group showed higher mean powers of total frequency (TF) (p=0.012), very low frequency (VLF) (p= 0.038), and low frequency (LF) (p=0.002) than the moderate OSAS group. The LF/HF ratio (p=0.005) was higher in the severe group compared to that of the moderate group. On the time domain analysis, the HRV triangular index (p=0.026) of severe OSAS group was significantly higher. AHI was correlated best with the LF/HF ratio (r(p)=0.610, p<0.001) of all the HRV indices. According to the results, the frequency domain indices tended to reveal the difference between the groups better than time domain indices. Especially the LF/HF ratio was thought to be the most useful parameter to estimate the degree of AHI in OSAS patients.
Adult
;
Cardiovascular Diseases/*diagnosis/pathology
;
Electrocardiography/methods
;
*Heart Rate
;
Humans
;
Male
;
Middle Aged
;
Oximetry
;
Oxygen/metabolism
;
Plethysmography
;
Polysomnography/methods
;
Sleep
;
Sleep Apnea, Obstructive/*diagnosis/pathology
6.The Surgical Treatment of Malignant Bowel Obstruction Caused by Recurrent Gastric Cancer.
Byung Eun YOO ; Joong Min PARK ; You Jin JANG ; Jong Han KIM ; Sung Soo PARK ; Seong Heum PARK ; Seong Ju KIM ; Young Jae MOK ; Chong Suk KIM
Journal of the Korean Gastric Cancer Association 2008;8(3):148-153
PURPOSE: Malignant bowel obstruction caused by recurrent gastric cancer must be treated appropriately to improve the effects of treatment and to prolong survival. We reviewed the surgical treatments for malignant bowel obstruction caused by recurrent gastric cancer. MATERIALS AND METHODS: The subjects were patients with malignant bowel obstruction caused by recurrent gastric cancer and these patients were treated by surgical procedures at our hospital from 1998 to 2008. The patients were treated by resection, ostomy or bypass. The success of treatment was decided when the patients were able to tolerate more than a liquid diet. RESULTS: 42 patients were treated 46 times by surgical procedures. Resection was done12 times, ostomy was done 24 times and bypass was done 10 times. The hospital stay and the period to liquid diet after the operation were shorter in the ostomy group. The post operative morbidity rate was 21.7% and the post operative death rate was 8.7%. There was no significant difference in survival according to the type of surgery. CONCLUSION: Ostomy is good choice for selected patients because it has a shorter hospital stay and period to liquid diet. There was no significant difference in survival according to the type of surgery because curative resection is difficult to perform in patients with malignant bowel obstruction.
Diet
;
Humans
;
Length of Stay
;
Ostomy
;
Stomach Neoplasms
7.Low Molecular Weight Heparin Treatment in Pregnant Women with a Mechanical Heart Valve Prosthesis.
Jae Hoon LEE ; Nam Hee PARK ; Dong Yoon KEUM ; Sae Young CHOI ; Ki Young KWON ; Chi Heum CHO
Journal of Korean Medical Science 2007;22(2):258-261
No definitive recommendation is available concerning optimal antithrombotic therapy in pregnant women with a mechanical heart valve. The purpose of the current study was to evaluate the clinical results of nadroparin treatment with respect to pregnancy outcome and maternal complications. From 1997 to 2005, 31 pregnancies were reviewed in 25 women. Nadroparin (7,500 U, twice daily) was used in 23 pregnancies between 6 and 12 weeks of gestation and close-to-term only, and coumarin derivatives were used with aspirin at other times. Eight pregnant women treated with coumarin derivatives throughout pregnancy were compared to evaluate the safety and efficacy of nadroparin. No maternal death or bleeding complication occurred in either of the two groups, and frequencies of maternal thromboembolism including valve thrombosis (8.7% vs. 12.5%, p>0.05) were similar. However, the frequencies of live born (91.3% vs. 50%, p=0.01) and healthy babies (90.4% vs. 25%, p<0.01) were significantly higher, and the fetal loss rate was significantly lower (8.7% vs. 50%, p=0.01) in the nadroparin-treated group. Regarding the efficacy and safety of antithrombotic treatment in pregnant women with prosthetic heart valves, nadroparin treatment during the first trimester is an acceptable regimen and produces better results than coumarin derivatives.
Treatment Outcome
;
Thrombosis/etiology/*prevention & control
;
Pregnancy Outcome
;
Pregnancy Complications, Cardiovascular/*etiology/*prevention & control
;
Pregnancy
;
Nadroparin/*administration & dosage/*adverse effects
;
Hydrocephalus/chemically induced
;
Humans
;
Heart Valve Prosthesis/*adverse effects
;
Heart Valve Diseases/etiology/*prevention & control
;
Female
;
Coumarins/administration & dosage
;
Adult
8.Effects of Methylprednisolone on the Neural Conduction of the Motor Evoked Potentials in Spinal Cord Injured Rats.
Bae Hwan LEE ; Kyung Hee LEE ; Do Heum YOON ; Un Jeng KIM ; Yong Soon HWANG ; Sang Keun PARK ; Joong Uhn CHOI ; Yong Gou PARK
Journal of Korean Medical Science 2005;20(1):132-138
Methylprednisolone (MP), a glucocorticoid steroid, has an anti-inflammatory action and seems to inhibit the formation of oxygen free radicals produced during lipid peroxidation in a spinal cord injury (SCI). However, the effects of MP on the functional recovery after a SCI is controversial. The present study was conducted to determine the effects of MP on the recovery of neural conduction following a SCI. A SCI was produced using the NYU spinal cord impactor. A behavioral test was conducted to measure neurological disorders, and motor evoked potentials (MEPs) were recorded. According to the behavioral test, using BBB locomotor scaling, MP-treated animals showed improved functional recoveries when compared to salinetreated animals. MEP latencies in the MP-treated group were shortened when compared to those in the control group. Peak amplitudes of MEPs were larger in the MP-treated group than those in the control group. The thresholds of MEPs tended to be lower in the MP-treated group than those in the control group. These results suggest that MP may improve functional recovery after a SCI.
Animals
;
Disease Models, Animal
;
Electrophysiology
;
Evoked Potentials, Motor/*drug effects
;
Free Radicals
;
Glucocorticoids/metabolism
;
Male
;
Methylprednisolone/*pharmacology
;
Neurons/*drug effects
;
Oxygen/metabolism
;
Rats
;
Rats, Sprague-Dawley
;
Receptors, Glucocorticoid/metabolism
;
Research Support, Non-U.S. Gov't
;
Sodium Chloride/pharmacology
;
Spinal Cord/pathology
;
Spinal Cord Injuries/*drug therapy
;
Time Factors
9.Report of Nation-wide Questionnaire Survey for Abdominal Aortic Aneurysm Treatment in Korea.
Young Wook KIM ; Seung Kee MIN ; Yong Bok KOH ; Seung Nam KIM ; Jang Sang PARK ; In Sung MOON ; Sang Woo PARK ; Seung HUH ; Jun Young CHOI ; Hochul PARK ; Won Hyun CHO ; Hyoung Tae KIM ; Ki Hyuk PARK ; Jung Ahn RHEE ; Kwang Jo CHO ; Sung Woon CHUNG ; Yong Shin KIM ; Dong Ik KIM ; Young Soo DO ; Sang Joon KIM ; Jongwon HA ; Jae Hyung PARK ; Hyuk AHN ; Taeseung LEE ; Joong Haeng CHOH ; Doosang KIM ; Won Heum SHIM ; Do Yun LEE ; Koing Bo KWUN ; Bo Yang SUH ; Woo Hyung KWUN ; Yong Pil CHO ; Geun Eun KIM ; Tae Won KWON ; Hong Rae CHO ; Byung Jun SO ; Hee Jae JUN ; Shin Kon KIM ; Sang Young CHUNG ; Soo Jin Na CHOI ; Sung Hwan KIM ; Jeong Hwan CHANG ; Lee Chan JANG ; In Gyu KIM ; Hyun Chul KIM
Journal of the Korean Society for Vascular Surgery 2005;21(1):10-15
While endovascular aneurysm repair (EVAR) is prevailing for the treatment of abdominal aortic aneurysm (AAA) in modern vascular practice, PURPOSE: we conducted nationwide questionnaire survey to investigate the current status of AAA treatment and their results in Korea. METHOD: We reviewed the replies from 28 hospitals (33 departments) to the questionnaire inquiring annual number, clinical features, mode of treatment and results of AAA patients during the period from Jan. 2000 to Jul. 2004. Results: 980 AAA patients were reported including 292 ruptured AAA (29.8%) and 688 non-ruptured AAA (70.2%). For treatment of AAA, 834 (85.1%) surgical repairs (SRs) and 111 (11.3%) endovascualr aneurysm repairs (EVARs) were performed while 35 patients (3.6%) died of AAA rupture before operation. The locations of AAA were infrarenal in 889 (90.7%), juxtarenal in 62 (6.3%), and suprarenal in 29 patients (3.0%). Among 834 patients undergoing SR, 577 patients (69.2%) had non-ruptured AAAs and 257 patients (30.8%) had ruptured AAAs. Mean operative mortality rate was 4.1% after elective SRs, 30.7% after SR for ruptured AAAs, and 2.3% after EVARs. The reported brand name of stent graft devices were various including domestic custom-made in 56 (50.5%), imported brand in 18 (16.2%) while 37 (33.3%) stent grafts were not reported their brand name. The frequencies of type I and III endoleaks after EVAR were reported 5.8% and 5.8% respectively in 86 patients with an available data. CONCLUSION: SR has been used as a major treatment option in Korea for the treatment of AAA patients while EVAR is increasing. The mortality rate of SR of AAA was comparable to western multi-center trial reports but mortality or morbidity rates of EVAR were unable to know in this questionnaire survey.
Aneurysm
;
Aortic Aneurysm
;
Aortic Aneurysm, Abdominal*
;
Blood Vessel Prosthesis
;
Endoleak
;
Humans
;
Korea*
;
Mortality
;
Questionnaires*
;
Rupture
;
Treatment Outcome
10.Intravenous leiomyomatosis with intracardiac extension: intracardiac leiomyomatosis-case report and literature review.
Jae Hun JUNG ; Pil Ki MIN ; So Young PARK ; Young Sup BYUN ; Geu Ru HONG ; Se Joong RIM ; Won Heum SHIM
Korean Journal of Medicine 2003;65(2):256-260
Intravenous leiomyomatosis is a rare benign vascular tumor defined as the extension into venous channels of a histologically benign smooth muscle tumor arising either from a uterus or from the walls of uterine vessels, and about 10% spread to the heart. The treatment of choice is complete resection of the tumor. Hormonal therapy should be considered in cases of unresectable residual tumor. A 46-year-old woman was admitted for abdominal discomfort and pain. She was found to have intravenous leiomyomatosis of the uterus with extension into inferior vena cava and right atrium. The patient underwent surgery employing simultaneous sternotomy and laparotomy. Radical excision was achieved using cardiopulmonary bypass. We herein describe a patient in whom complete removal of intravenous leiomyomatosis with cardiac extension was successfully performed.
Cardiopulmonary Bypass
;
Female
;
Heart
;
Heart Atria
;
Humans
;
Laparotomy
;
Leiomyomatosis*
;
Middle Aged
;
Neoplasm, Residual
;
Smooth Muscle Tumor
;
Sternotomy
;
Uterus
;
Vena Cava, Inferior

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