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.

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.

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.

Background: The primary objective of this study was to assess the clinical effectiveness of fused images obtained from single-photon emission computed tomography (SPECT) and facial computed tomography (CT) for evaluat‑ ing degenerative changes in the mandibular condylar head. This assessment was accomplished by comparing the Technetium-99 m methylene diphosphonate ( 99m Tc-MDP) uptake ratio with the results of clinical and radiographic findings. Methods: The study included 17 patients (3 males and 14 females) with suspected osteoarthritis of the mandibular condyle, totaling 34 temporomandibular joints (TMJs). Based on clinical and radiographic examinations, the TMJs were categorized into four groups: normal (group N), internal derangement (group ID), osteoarthritis (group OA), and osteoarthritis sequelae (group ­OA seq ). For each patient, bone SPECT and facial CT scans were registered and reconstructed to create fused SPECT/CT images. The 99m Tc-MDP uptake levels in the TMJs were statistically com‑ pared among the four groups. Results: The 99m Tc-MDP uptake ratio showed a gradual increase in the order of the following: group N, group OA seq , group ID, and group OA. There was a significant difference observed among groups (pConclusion Fused SPECT/CT image can be an effective tool for evaluating degenerative changes in the mandibular condylar head. The technique demonstrated the ability to differentiate between normal TMJs and those with internal derangement, osteoarthritis, or osteoarthritis sequelae. This approach holds promise as a valuable method in clinical assessments of TMJ degeneration.

It is challenging to treat ventriculitis with parenteral treatment alone in some cases because of the difficulty involved in maintaining an appropriate level of antibiotics in cerebrospinal fluid (CSF). We report two cases of ventriculitis who did not respond to intravenous (IV) antibiotics but were successfully treated with intraventricular antibiotics using IV agents. The first case was a four-month-old male patient with X-linked hydrocephalus.He showed ventriculitis due to Klebsiella pneumoniae not producing extended-spectrum β-lactamase and susceptible to third-generation cephalosporins and gentamicin, following ventriculoperitoneal (VP) shunt. His condition did not improve during the 47 days of treatment with IV cefotaxime and meropenem. We achieved improvement in clinical presentation and CSF profile after three times of intraventricular gentamicin injection. The patient was discharged from the hospital with antiepileptic drugs. The second case was a six-month-old female patient with a history of neonatal meningitis complicated with hydrocephalus at one month of age, VP shunt at two months of age, followed by a methicillinresistant coagulase-negative staphylococci (CoNS) shunt infection with ventriculitis after the shunt operation. CoNS ventriculitis recurred four weeks later. We failed to treat intractable methicillin-resistant CoNS ventriculitis with IV vancomycin for ten days, and thus intraventricular antimicrobial treatment was considered. Five times of intraventricular vancomycin administration led to improvement in clinical parameters. There were only neurological sequelae of delayed language development but no other major complications. Patients in these two cases responded well to intraventricular antibiotics, with negative CSF culture results, and were successfully treated for ventriculitis without serious complications.

BACKGROUND: We have designed a reinforced drug-loaded vascular graft composed of polycaprolactone (PCL) and polydioxanone (PDO) via a combination of electrospinning/3D printing approaches. To evaluate its potential for clinical application, we compared the in vivo blood compatibility and performance of PCL/PDO ? 10%DY grafts doped with an antithrombotic drug (dipyridamole) with a commercial expanded polytetrafluoroethylene (e-PTFE) graft in a porcine model. METHODS: A total of 10 pigs (weight: 25–35 kg) were used in this study. We made a new 5-mm graft with PCL/PDO composite nanofiber via the electrospinning technique. We simultaneously implanted a commercially available e-PTFE graft (n = 5) and our PCL/PDO ? 10%DY graft (n = 5) into the carotid arteries of the pigs. No anticoagulant/antiplatelet agent was administered during the follow-up period, and ultrasonography was performed weekly to confirm the patency of the two grafts in vivo. Four weeks later, we explanted and compared the performance of the two grafts by histological analysis and scanning electron microscopy (SEM). RESULTS: No complications, such as sweating on the graft or significant bleeding from the needle hole site, were seen in the PCL/PDO ? 10%DY graft immediately after implantation. Serial ultrasonographic examination and immunohistochemical analysis demonstrated that PCL/PDO ? 10%DY grafts showed normal physiological blood flow and minimal lumen reduction, and pulsed synchronously with the native artery at 4 weeks after implantation. However, all e-PTFE grafts occluded within the study period. The luminal surface of the PCL/PDO ? 10%DY graft in the transitional zone was fully covered with endothelial cells as observed by SEM. CONCLUSION The PCL/PDO ? 10%DY graft was well tolerated, and no adverse tissue reaction was observed in porcine carotid models during the short-term follow-up. Colonization of the graft by host endothelial and smooth muscle cells coupled with substantial extracellular matrix production marked the regenerative capability. Thus, this material may be an ideal substitute for vascular reconstruction and bypass surgeries. Long-term observations will be necessary to determine the anti-thrombotic and remodeling potential of this device.

Background: Endoscopy is used for diagnosing and treating various digestive diseases in children as well as in adults. However, in pediatric patients, it is recommended that sufficient sedation should be ensured before conducting endoscopy, since insufficient sedation may cause serious complications. However, in Korea, no studies have yet described the types of sedation drugs, effects of sedation, and efficiency of endoscopy with respect to the sedation instructor. Thus, we investigated the effectiveness of sedative procedures performed by anesthesiologists. Methods: We retrospectively reviewed the medical records of patients aged < 18 years who underwent endoscopy during March 2014–July 2019. Data of sedation instructors, sedation drugs and their doses, complications, and the recovery after sedation were evaluated. Results: Of 257 patients, 217 underwent esophagogastroduodenoscopy (EGD) and 40 underwent colonoscopies. Before EGD, 29 patients (13.4%) underwent sedation by the pediatric endoscopist and 188 (86.6%) were sedated by the anesthesiologist. The anesthesiologist performed the sedation for all 40 patients who underwent colonoscopy. Endoscopic examinations performed by the anesthesiologist were relatively more time-consuming (401.0 ± 135.1 seconds vs. 274.9 ± 106.1 seconds, P < 0.001). We observed that in patients who underwent EGD, there was a difference in the dose of midazolam administered (P = 0.000). When comparing EGD and colonoscopy in patients undergoing sedation by the anesthesiologist, there were no significant differences in the doses of midazolam and ketamine, but the dose of propofol increased for colonoscopy (2.50 ± 0.95 mg/kg vs. 4.71 ± 1.66 mg/kg, P = 0.000). The cognitive recovery time according to drug dose was associated with propofol only in EGD with a shorter endoscopy time. The longer cognitive recovery time in colonoscopy and the discharge time of EGD and colonoscopies were not associated with propofol use. Conclusion When sedation is performed by an anesthesiologist, various drugs are used with sufficient doses and complications are reduced, but the discharge time does not change. For performing pediatric endoscopy in Korea, anesthesiologists should be considered for inducing anesthesia.

Purpose: To investigate the safety of and adherence to a prehabilitation program among patients with endometrial cancer and to provide preliminary evidence of the program’s efficacy in terms of health-related fitness (HRF) and patient-reported outcomes. Methods: Nineteen patients with endometrial cancer were recruited in a 2-week trial for a one-on-one supervised exercise program. All patients participated in an individual exercise program—the Challenge, Overcome, Resolve, and Enhance (CORE) program—which consisted of 60 minutes of moderate-to-vigorous intensity resistance, core stability, and aerobic exercise, supervised five times within 2 weeks before surgery. Results: Seventeen (89.5%) of the 19 participants completed the CORE program, and no adverse events occurred. All participants accomplished the daily mean step counts and sustained the prescribed target heart rate (reserve 50%–60%) during the CORE program sessions. Participants who completed the exercise program exhibited significantly improved HRF (cardiorespiratory fitness, 30-second chair stand, hand grip strength, curl-ups, sit and reach, single-leg standing with closed eyes; p＜0.001 for all) without changes in the body mass index (p=0.113). Their quality of life (general, p=0.001; function, p=0.001; symptom, p=0.003), symptom clusters (p=0.006), anxiety (p＜0.001), and depression (p＜0.001) were significantly improved. Conclusion The 2-week prehabilitation CORE program is safe and feasible for patients scheduled to undergo surgery for early-stage endometrial cancer and may improve their physical and psychological health status.

BACKGROUND: An increase in the numbers of patients with gastrointestinal symptoms has recently been observed. PURPOSE: To investigate the effects of proton pump inhibitor (PPI) therapy on intestinal inflammation in children and adolescents as confirmed by clinical manifestations and objectively assessed by fecal calprotectin (FC) level measurement. METHODS: Consecutive children (aged 3–18 years) who presented with gastrointestinal symptoms and were treated with or without PPI for at least 1 month were enrolled. Patients were divided into PPI and non-PPI groups. The PPI group was further subdivided by treatment duration and type of PPI used. Stool samples were collected for FC evaluation at baseline and after treatment and clinical data and FC levels were compared between the groups. RESULTS: Fifty-one patients (15 boys, 36 girls) were enrolled in the study. The PPI group included 37 patients, while the non-PPI group included 14 patients. Clinical symptoms were not significantly different. FC levels and laboratory results, including C-reactive protein levels, white blood cell count, and absolute neutrophil count, were not statistically different before versus after PPI treatment. After treatment, FC levels decreased to 8.1 mg/kg (-575.4 to 340.3 mg/kg) in the PPI group and increased to 5.6 mg/kg (-460.0 to 186.9 mg/kg) in the non-PPI group compared to those before treatment (P=0.841). The number of patients with increased FC levels was not significantly different between the 2 groups (48.6% vs. 64.3%, P=0.363), similar to that observed in patients with an FC level > 50 mg/kg (24.3% and 7.1%, P=0.250). PPI therapy type and duration did not affect the FC levels (P=0.811 and P=0.502, respectively). CONCLUSION: Although we aimed to confirm the evidence of intestinal inflammation due to PPI use in children and adolescents through clinical symptoms and FC measurement, no significant changes were observed.
Adolescent ; C-Reactive Protein ; Child ; Humans ; Inflammation ; Leukocyte Count ; Leukocyte L1 Antigen Complex ; Neutrophils ; Proton Pump Inhibitors ; Proton Pumps ; Protons

BACKGROUND: A single-arm phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in the treatment of advanced-stage ovarian cancer has begun in Korea. We hypothesized that adding durvalumab (anti-programmed death-ligand 1 antibody) and tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4 antibody) to chemotherapy in treating this cancer can increase progression-free survival (PFS) with minimal effects on safety. METHODS: During treatment, serial biopsies will be performed on pre-treatment, at interval debulking surgery and progression to identify immune biomarkers and changes in the tumor microenvironment. Patients with histologically confirmed stage IIIC/IV epithelial ovarian cancer are offered durvalumab, tremelimumab plus chemotherapy for neoadjuvant chemotherapy and durvalumab plus chemotherapy for adjuvant chemotherapy. Twenty-four patients will be included from four Korean institutions within 1 year. The primary endpoint is a 12-month PFS rate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03899610
Biomarkers ; Biopsy ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Drug Therapy ; Humans ; Immunotherapy ; Korea ; Ovarian Neoplasms ; Tumor Microenvironment