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.Predicting the Progression of Mild Cognitive Impairment to Alzheimer’s Dementia Using Recurrent Neural Networks With a Series of Neuropsychological Tests
Chaeyoon PARK ; Gihun JOO ; Minji ROH ; Seunghun SHIN ; Sujin YUM ; Na Young YEO ; Sang Won PARK ; Jae-Won JANG ; Hyeonseung IM ; For the Alzheimer’s DISEASE NEUROIMAGING INITIATIVE
Journal of Clinical Neurology 2024;20(5):478-486
Background:
and Purpose The prevalence of Alzheimer’s dementia (AD) is increasing as populations age, causing immense suffering for patients, families, and communities. Unfortunately, no treatments for this neurodegenerative disease have been established. Predicting AD is therefore becoming more important, because early diagnosis is the best way to prevent its onset and delay its progression.
Methods:
Mild cognitive impairment (MCI) is the stage between normal cognition and AD, with large variations in its progression. The disease can be effectively managed by accurately predicting the probability of MCI progressing to AD over several years. In this study we used the Alzheimer’s Disease Neuroimaging Initiative dataset to predict the progression of MCI to AD over a 3-year period from baseline. We developed and compared various recurrent neural network (RNN) models to determine the predictive effectiveness of four neuropsychological (NP) tests and magnetic resonance imaging (MRI) data at baseline.
Results:
The experimental results confirmed that the Preclinical Alzheimer’s Cognitive Composite score was the most effective of the four NP tests, and that the prediction performance of the NP tests improved over time. Moreover, the gated recurrent unit model exhibited the best performance among the prediction models, with an average area under the receiver operating characteristic curve of 0.916
Conclusions
Timely prediction of progression from MCI to AD can be achieved using a series of NP test results and an RNN, both with and without using the baseline MRI data.
5.A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation
Guk Jin LEE ; Hyunho KIM ; Sung Shim CHO ; Hyung Soon PARK ; Ho Jung AN ; In Sook WOO ; Jae Ho BYUN ; Ji Hyung HONG ; Yoon Ho KO ; Der Sheng SUN ; Hye Sung WON ; Jong Youl JIN ; Ji Chan PARK ; In-Ho KIM ; Sang Young ROH ; Byoung Yong SHIM
Journal of Gastric Cancer 2023;23(2):315-327
Purpose:
Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy.
Materials and Methods:
Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level.
Results:
Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020).
Conclusions
After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.
6.Added Value of Contrast Leakage Information over the CBV Value of DSC Perfusion MRI to Differentiate between Pseudoprogression and True Progression after Concurrent Chemoradiotherapy in Glioblastoma Patients
Elena PAK ; Seung Hong CHOI ; Chul-Kee PARK ; Tae Min KIM ; Sung-Hye PARK ; Jae-Kyung WON ; Joo Ho LEE ; Soon-Tae LEE ; Inpyeong HWANG ; Roh-Eul YOO ; Koung Mi KANG ; Tae Jin YUN
Investigative Magnetic Resonance Imaging 2022;26(1):10-19
Purpose:
To evaluate whether the added value of contrast leakage information from dynamic susceptibility contrast magnetic resonance imaging (DSC MRI) is a better prognostic imaging biomarker than the cerebral blood volume (CBV) value in distinguishing true progression from pseudoprogression in glioblastoma patients.
Materials and Methods:
Forty-nine glioblastoma patients who had undergone MRI after concurrent chemoradiotherapy with temozolomide were enrolled in this retrospective study. Twenty features were extracted from the normalized relative CBV (nCBV) and extraction fraction (EF) map of the contrast-enhancing region in each patient. After univariable analysis, we used multivariable stepwise logistic regression analysis to identify significant predictors for differentiating between pseudoprogression and true progression. Receiver operating characteristic (ROC) analysis was employed to determine the best cutoff values for the nCBV and EF features. Finally, leave-one-out cross-validation was used to validate the best predictor in differentiating between true progression and pseudoprogression.
Results:
Multivariable stepwise logistic regression analysis showed that MGMT (O 6 -methylguanine-DNA methyltransferase) and EF max were independent differentiating variables (P = 0.004 and P = 0.02, respectively). ROC analysis yielded the best cutoff value of 95.75 for the EF max value for differentiating the two groups (sensitivity, 61%; specificity, 84.6%; AUC, 0.681 ± 0.08; 95% CI, 0.524-0.837; P = 0.03). In the leave-one-out cross-validation of the EF max value, the cross-validated values for predicting true progression and pseudoprogression accuracies were 69.4% and 71.4%,respectively.
Conclusion
We demonstrated that contrast leakage information parameter from DSC MRI showed significance in differentiating true progression from pseudoprogression in glioblastoma patients.
7.Optimal indication of single-incision laparoscopic cholecystectomy using Konyang Standard Method in benign gallbladder diseases
Seung Jae LEE ; In Seok CHOI ; Ju Ik MOON ; Dae Sung YOON ; Won Jun CHOI ; Sang Eok LEE ; Nak Song SUNG ; Seong Uk KWON ; In Eui BAE ; Seung Jae ROH ; Sung Gon KIM
Journal of Minimally Invasive Surgery 2022;25(3):97-105
Purpose:
The optimal indications for single-incision laparoscopic cholecystectomy (SILC) have not yet been established.
Methods:
This single-center retrospective study included consecutive patients who underwent SILC between April 2010 and June 2020. Dif f icult surger y (DS) (conversion to multiport or open cholecystectomy, adjacent organ injury, operation time of ≥90 minutes, or estimated blood loss of ≥100 mL) and poor postoperative outcome (PPO) (postoperative hospital stay ≥ 7 days or Clavien-Dindo grade ≥ II postoperative complications) were def ined to comprehensively evaluate surgical diff iculty and postoperative outcomes, respectively.
Results:
Of 1,405 patients (mean age, 51.2 years; 802 female [57.1%]), 427 (grade I, n = 358; grade II/III, n = 69) underwent SILC for acute cholecystitis (AC), 34 (2.4%) needed conversion to multiport (n = 33) or open cholecystectomy (n = 1), 7 (0.5%) had adjacent organ injury during surgery, and 49 (3.5%) developed postoperative complications. Of the patients, 89 and 52 had DS and PPO, respectively. In the multivariate analysis, grade I AC, grade II/III AC, and body mass index of ≥30 kg/m 2 were significant predictors of DS.Age of ≥70 years and DS were significant predictors of PPO. In a subgroup analysis of patients with AC, DS (9.5% vs. 27.5%, p < 0.001) and PPO (5.0% vs. 15.9%, p = 0.001) were more frequent in patients with grade II/III AC than in those with grade I AC.
Conclusion
SILC is not recommended in patients with grade II/III AC and should be carefully performed by experienced and well-trained surgeons.
8. 18 FTHK-5351 PET Patterns in Patients With Alzheimer’s Disease and Negative Amyloid PET Findings
Minyoung OH ; Jungsu S. OH ; Seung Jun OH ; Sang Ju LEE ; Jee Hoon ROH ; Woo Ram KIM ; Ha-Eun SEO ; Jae Myeong KANG ; Sang Won SEO ; Jae-Hong LEE ; Duk L. NA ; Young NOH ; Jae Seung KIM
Journal of Clinical Neurology 2022;18(4):437-446
Background:
and Purpose Alzheimer’s disease (AD) does not always mean amyloid positivity. [ 18 F]THK-5351 has been shown to be able to detect reactive astrogliosis as well as tau accompanied by neurodegenerative changes. We evaluated the [ 18 F]THK-5351 retention patterns in positron-emission tomography (PET) and the clinical characteristics of patients clinically diagnosed with AD dementia who had negative amyloid PET findings.
Methods:
We performed 3.0-T magnetic resonance imaging, [ 18 F]THK-5351 PET, and amyloid PET in 164 patients with AD dementia. Amyloid PET was visually scored as positive or negative. [ 18 F]THK-5351 PET were visually classified as having an intratemporal or extratemporal spread pattern.
Results:
The 164 patients included 23 (14.0%) who were amyloid-negative (age 74.9±8.3 years, mean±standard deviation; 9 males, 14 females). Amyloid-negative patients were older, had a higher prevalence of diabetes mellitus, and had better visuospatial and memory functions. The frequency of the apolipoprotein E ε4 allele was higher and the hippocampal volume was smaller in amyloid-positive patients. [ 18 F]THK-5351 uptake patterns of the amyloid-negative patients were classified into intratemporal spread (n=10) and extratemporal spread (n=13).Neuropsychological test results did not differ significantly between these two groups. The standardized uptake value ratio of [ 18 F]THK-5351 was higher in the extratemporal spread group (2.01±0.26 vs. 1.61±0.15, p=0.001). After 1 year, Mini Mental State Examination (MMSE) scores decreased significantly in the extratemporal spread group (-3.5±3.2, p=0.006) but not in the intratemporal spread group (-0.5±2.8, p=0.916). The diagnosis remained as AD (n=5, 50%) or changed to other diagnoses (n=5, 50%) in the intratemporal group, whereas it remained as AD (n=8, 61.5%) or changed to frontotemporal dementia (n=4, 30.8%) and other diagnoses (n=1, 7.7%) in the extratemporal spread group.
Conclusions
Approximately 70% of the patients with amyloid-negative AD showed abnormal [ 18 F]THK-5351 retention. MMSE scores deteriorated rapidly in the patients with an extratemporal spread pattern.
9.Optimal drain management following complicated laparoscopic cholecystectomy for acute cholecystitis: a propensity-matched comparative study
Seung Jae LEE ; In Seok CHOI ; Ju Ik MOON ; Dae Sung YOON ; Won Jun CHOI ; Sang Eok LEE ; Nak Song SUNG ; Seong Uk KWON ; In Eui BAE ; Seung Jae ROH ; Sung Gon KIM
Journal of Minimally Invasive Surgery 2022;25(2):63-72
Purpose:
This study was performed to investigate the effect of drain placement on complicated laparoscopic cholecystectomy (cLC) for acute cholecystitis (AC).
Methods:
This single-center retrospective study reviewed patients with AC who underwent cLC between January 2010 and December 2020. cLC was defined as open conversion, subtotal cholecystectomy, adjacent organ injury during surgery, operation time of ≥90 minutes, or estimated blood loss of ≥100 mL. One-toone propensity score matching was performed to compare the surgical outcomes between patients with and without drain on cLC.
Results:
A total of 216 patients (mean age, 65.8 years; 75 female patients [34.7%]) underwent cLC, and 126 (58.3%) underwent intraoperative abdominal drainage. In the propensity score-matched cohort (61 patients in each group), early drain removal (≤postoperative day 3) was performed in 42 patients (68.9%). The overall rate of surgical site infection (SSI) was 10.7%. Late drain removal demonstrated significantly worse surgical outcomes than no drain placement and early drain removal for overall complications (13.1% vs. 21.4% vs. 47.4%, p = 0.006), postoperative hospital stay (3.8 days vs. 4.4 days vs. 12.7 days, p < 0.001), and SSI (4.9% vs. 11.9% vs. 31.6%, p = 0.006). In the multivariate analysis, late drain removal was the most significant risk factor for organ space SSI.
Conclusion
This study demonstrated that drain placement is not routinely recommended, even after cLC for AC. When placing a drain, early drain removal is recommended because late drain removal is associated with a higher risk of organ space SSI.
10.Mortality-Related Risk Factors in Total Hip Arthroplasty for Femoral Neck Fractures in Elderly Patients
Jae Sung SUH ; Hyung Gon RYU ; Young Ju ROH ; Dae Won SHIN
Journal of the Korean Fracture Society 2022;35(2):51-56
Purpose:
Total hip arthroplasty (THA) using dual mobility components (DMC) is a reasonable surgical option for displaced femoral neck fractures in elderly patients, resulting in lower dislocation rates and improved stability. The purpose of this study was to investigate the clinical outcomes and risk factors responsible for mortality in elderly patients who were diagnosed with a displaced femoral neck fracture and had undergone DMC-THA.
Materials and Methods:
Out of 147 cases of THA from December 2018 to June 2020, a total of 79 cases were enrolled in this study, with the following characteristics: (1) Garden stage III or IV, (2) over 75 years of age, and (3) over 1 year of follow-up. All the patients received DMC-THA surgery using the anterolateral approach.
Results:
The mean follow-up period was 15.0±8.43 months and a total of one dislocation case was observed. The mortality rate was 17.7% (14/79), and it was especially higher in patients with a past medical history of malignancy (odds ratio [OR]=7.18, p=0.03) or a cognitive disorder such as dementia (OR=5.48, p=0.03). Preoperative low initial hemoglobin levels (OR=0.65, p=0.04) and low UCLA (Uni-versity of California at Los Angeles) score (OR=0.47, p=0.02) were also associated with mortality.
Conclusion
When considering THA as a treatment approach in elderly patients with a displaced femoral neck fracture, a high mortality rate is expected in patients with low preoperative hemoglobin levels or a history of malignancy or cognitive disorders. Hence, thorough monitoring and management should be undertaken before and after surgery.

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