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.Validation and Reliability of the Cataract-related Visual Function Questionnaire (CVFQ)
Eun Jin KOH ; Jong Min LEE ; Dong Hui LIM ; Danbee KANG ; Juhee CHO ; Min Kyung SONG ; In Kwon CHUNG ; Hun Jin CHOI ; Ji Woong CHANG ; Jong Hyun LEE ; Tae Young CHUNG ; Young Sub EOM ; Yeoun Sook CHUN ; So Hyang CHUNG ; Eun Chul KIM ; Joon Young HYON ; Do Hyung LEE
Journal of the Korean Ophthalmological Society 2023;64(11):1030-1040
Purpose:
To evaluate the reliability and validity of the Cataract-related Visual Function Questionnaire (CVFQ).
Methods:
A prospective cross-sectional study of 141 cataract patients was conducted from March 2022 to June 2022. The questionnaire was created based on a literature review and advice from an expert panel. This study determined its construct validity, criterion validity, internal consistency, and test-retest reliability.
Results:
The CVFQ consists of 15 items distributed among five categories: overall visual quality, overall visual function, distance vision, near vision, and glare. In the exploratory factor analysis of validity, the first three principal components explained 77.8% of the variance. The p-values in the Spearman correlation test comparing the pre- and postoperative total CVFQ score and best-corrected visual acuity (BCVA) were 0.006 and 0.004, respectively. In the reliability analysis, Cronbach’s alpha was > 0.9 for internal consistency and the p-values of each subcategory were all significant in the analysis of test-retest reliability.
Conclusions
Our results indicate that the CVFQ is useful for measuring the visual quality and visual function of cataract patients in Korea.
5.Treatment Outcome of Gamma Knife Radiosurgery for Petroclival Meningiomas: Retrospective Analysis of a Single Institution Experience
Myeong-Hun HA ; Woo-Youl JANG ; Tae-Young JUNG ; In-Young KIM ; Sa-Hoe LIM ; Kyung-Sub MOON ; Shin JUNG
Brain Tumor Research and Treatment 2020;8(2):e16-
Background:
Although Gamma Knife radiosurgery (GKRS) has been widely used for intracranial meningiomas as an alternative or adjuvant treatment, guidelines have not been established for the selection of patients with petroclival meningioma (PCM) for GKRS. In this study, we reported the factors related to tumor progression and postoperative complications in PCM patients treated by GKRS, with a review of the literatures.
Methods:
Between 2004 and 2019, 64 patients (52 patients for alternative and 12 patients for adjuvant treatment) with PCM underwent GKRS in our institution. The clinical and radiological factors were retrospectively analyzed. The mean radiologic follow-up duration was 58.4 months (range, 6-164 months). The mean tumor volume and diameter before GKRS were 13.4㎤ and 2.9 cm, respectively.The median marginal dose was 12 Gy (range, 10-14 Gy) with a 50% median isodose line. Fractionation was used in 19 cases (29%, two fractionations in 5 cases & three fractionations in 14 cases).
Results:
Progression was noted in 7 cases (10.9%) and the progression-free survival rates were 91.1% at 5 years and 69.6% at 10 years. Although large in volume, moderate to severe peritumoral edema and male gender were somewhat related to progression, they did not reach statistical significance. Ten patients (15.6%) developed complications after GKRS. The most common complication was cranial nerve deficit (n=8), followed by hemiparesis, cognitive dysfunction, and hydrocephalus. Large size (maximal diameter ≥5 cm) [hazard ratio (HR) 0.091, 95% confidence interval (CI) 0.014-0.608;p=0.013] and multiplicity (HR 0.102, 95% CI 0.018-0.573; p=0.009) were independent factors for developing complications after GKRS.
Conclusion
GKRS can be considered an effective and safe treatment for large-volume PCM. However, for patients with large size or multiple masses, the treatment method should be determined with caution because the probability of complications after GKRS may increase.
6.Valacyclovir-Induced Neurotoxicity in a Maintenance Hemodialysis Patient.
June Seong HWANG ; Hyo Yoep SONG ; Hoon Gil JO ; Song I LEE ; Byung Hun LIM ; Jung Sub SONG ; Seon Ho AHN
Journal of the Korean Geriatrics Society 2014;18(2):85-88
Valacyclovir is an oral antiviral agent used in the treatment of herpesvirus infection. Although neuropsychiatric symptoms may accompany the use of this drug, valacyclovir is increasingly used to treat herpes zoster, as it is more effective when orally administered. This paper reports one case of neurotoxicity of valacyclovir in patients with end stage renal disease who were undergoing maintenance hemodialysis. Valacyclovir can induce life-threatening neurotoxicity, especially in end stage renal disease patients despite the appropriate dose reduction. Furthermore, Valacyclovir-induced neurotoxicity can be effectively managed by intensive hemodialysis.
Herpes Zoster
;
Herpesviridae Infections
;
Humans
;
Kidney Failure, Chronic
;
Renal Dialysis*
7.Comparison of Wettability for Ocular Prosthesis Depending on Different Kinds of Artificial Tear Eye Drops.
Se Ran JANG ; Il Suk YUN ; Hun Sub LIM ; Koung Hoon KOOK
Journal of the Korean Ophthalmological Society 2014;55(12):1745-1751
PURPOSE: In this study we compared the surface wettability of ocular prosthesis and depositions depending on different types of artificial tear eye drops. METHODS: The artificial tear eye drops contain sodium hyaluronate (HA) 0.1%, 0.18%, 0.3%, carboxylmethylcellulose sodium (CMC), hydroxymethylcelluose + dextran (HMC), propylene glycol + polyethylene glycol (PG), polysorbate 80 (PS) povidone (Pov) were evaluated. Flat rectangular parallelepiped blocks consisting of polymethylmethacrylate (PMMA) or silicone materials were made. One artificial tear eye drop was applied on the surface of two different blocks of artificial eyes using a 23-gauge needle. Then, the static method contact angle was measured by using a contact angle goniometer. To measure the deposits, a petri dish was covered with 3 mL of artificial tear eye drops and dried for 48 hours at room temperature. Then, the light transmittance at the center of the petri dish was measured to investigate the amount of the residue. RESULTS: The contact angles of HA 0.1%, 0.18%, 0.3%, CMC, HMC, PG, PS and Pov on PMMA were 78.69degrees, 84.29degrees, 75.46degrees, 80.93degrees, 66.29degrees, 71.26degrees, 58.40degrees and 70.24degrees, respectively. The contact angles on silicone were 53.68degrees, 60.87degrees, 64.46degrees, 62.78degrees, 38.89degrees, 63.58degrees, 30.68degrees and 51.41degrees, respectively. The largest decrease in transparency was observed in the artificial tear eye drops containing HMC. CONCLUSIONS: The wettability and deposits on the surface of ocular prosthesis can vary based on the components and concentration of artificial tear eye drops. The results from this study should be considered when choosing the right artificial tear eye drops for improving dry eye symptoms in patients wearing ocular prostheses.
Anophthalmos
;
Dextrans
;
Dry Eye Syndromes
;
Eye, Artificial*
;
Humans
;
Hyaluronic Acid
;
Needles
;
Ophthalmic Solutions*
;
Polyethylene Glycols
;
Polymethyl Methacrylate
;
Polysorbates
;
Povidone
;
Propylene Glycol
;
Silicones
;
Sodium
;
Tears*
;
Wettability*
8.Comparison of Wettability for Ocular Prosthesis Depending on Different Kinds of Artificial Tear Eye Drops.
Se Ran JANG ; Il Suk YUN ; Hun Sub LIM ; Koung Hoon KOOK
Journal of the Korean Ophthalmological Society 2014;55(12):1745-1751
PURPOSE: In this study we compared the surface wettability of ocular prosthesis and depositions depending on different types of artificial tear eye drops. METHODS: The artificial tear eye drops contain sodium hyaluronate (HA) 0.1%, 0.18%, 0.3%, carboxylmethylcellulose sodium (CMC), hydroxymethylcelluose + dextran (HMC), propylene glycol + polyethylene glycol (PG), polysorbate 80 (PS) povidone (Pov) were evaluated. Flat rectangular parallelepiped blocks consisting of polymethylmethacrylate (PMMA) or silicone materials were made. One artificial tear eye drop was applied on the surface of two different blocks of artificial eyes using a 23-gauge needle. Then, the static method contact angle was measured by using a contact angle goniometer. To measure the deposits, a petri dish was covered with 3 mL of artificial tear eye drops and dried for 48 hours at room temperature. Then, the light transmittance at the center of the petri dish was measured to investigate the amount of the residue. RESULTS: The contact angles of HA 0.1%, 0.18%, 0.3%, CMC, HMC, PG, PS and Pov on PMMA were 78.69degrees, 84.29degrees, 75.46degrees, 80.93degrees, 66.29degrees, 71.26degrees, 58.40degrees and 70.24degrees, respectively. The contact angles on silicone were 53.68degrees, 60.87degrees, 64.46degrees, 62.78degrees, 38.89degrees, 63.58degrees, 30.68degrees and 51.41degrees, respectively. The largest decrease in transparency was observed in the artificial tear eye drops containing HMC. CONCLUSIONS: The wettability and deposits on the surface of ocular prosthesis can vary based on the components and concentration of artificial tear eye drops. The results from this study should be considered when choosing the right artificial tear eye drops for improving dry eye symptoms in patients wearing ocular prostheses.
Anophthalmos
;
Dextrans
;
Dry Eye Syndromes
;
Eye, Artificial*
;
Humans
;
Hyaluronic Acid
;
Needles
;
Ophthalmic Solutions*
;
Polyethylene Glycols
;
Polymethyl Methacrylate
;
Polysorbates
;
Povidone
;
Propylene Glycol
;
Silicones
;
Sodium
;
Tears*
;
Wettability*
9.Annual Report on External Quality Assessment in Immunoassay in Korea (2009).
Hyon Suk KIM ; Young Lan KIM ; Jungyong PARK ; Oh Hun KWON ; Deog An KIM ; Jin Q KIM ; Young Kyu SUN ; Seob SHIN ; Hwan Sub LIM ; Hea Sun CHUN ; Young Soon JUNG
Journal of Laboratory Medicine and Quality Assurance 2010;32(1):103-114
Two trials with 15 test items of external quality assessment survey were performed in 2009. The test items were constituted three immunoassay categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items commonly used in clinical laboratories and performed by immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 494 institutions in the first trial survey and 519 institutions in the second survey. All of the fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used for the two trials in 2009 survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 494 and 519 laboratories and the response rate were 97.6% and 98.3% in 2009. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Stability tests of home-made control materials were performed and confirmed the CV values were in acceptable ranges. 4. Workshops titled "National health examination for tumors" and "Standardization and harmonization of laboratory tests" were held on September 4, 2009 and December 16, 2009 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control, and Immunoserology Subcommittee, respectively. The quality of the participating laboratories seems to be continuously improved. And, this year, new sixty eight laboratories were participated to our Immunoassay Subcommittee.
Congresses as Topic
;
Immunoassay
;
Immunoglobulin A
;
Immunoglobulin M
;
Immunoproteins
;
Korea
;
Quality Control
;
Thyroid Hormones
;
Biomarkers, Tumor
10.Results of Reconstruction of Orbital Wall Fracture With Bioresorbable Plate.
Journal of the Korean Ophthalmological Society 2009;50(12):1761-1767
PURPOSE: To investigate the long-term results and complications of orbital wall fracture reconstruction using the bioabsorbable orbital implant, Macropore(R) orbital floor liner. METHODS: This retrospective study included patients who underwent the reconstruction of an orbital wall fracture using Macropore(R) orbital floor liner and completed a postoperative follow-up longer than 6 months. The enophthalmic values as well as the data of ocular movement and diplopia was collected from the medical records of each patient and analyzed. RESULTS: A total of 35 patients were evaluated with an average follow-up period of 14.0 months. The average enophthalmic value of 29 patients, whose reconstruction was primarily indicated from enophthalmic tissue, was 0.90 mm at the last follow-up. No significant progression of enophthalmos was observed at postoperative 12, 18 and 24 months when compared with the enophthalmic value at postoperative 6 months. All 15 patients who have had the limitation of ocular movement or diplopia preoperatively resolved completely or improved to the degree that no clinically significant limitation or diplopia further existed. No complications such as dislocation of implant, infection, and aggravation of ocular limitation were observed during the follow-up period. CONCLUSIONS: Macropore(R) orbital floor liner may be regarded as a useful implant in reconstruction of orbital wall fracture with no significant implant-related complications during its absorption.
Absorption
;
Diplopia
;
Dislocations
;
Enophthalmos
;
Floors and Floorcoverings
;
Follow-Up Studies
;
Humans
;
Medical Records
;
Orbit
;
Orbital Implants
;
Retrospective Studies

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