Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

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.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

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.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.

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.

Objective: Fluoroscopy-guided percutaneous pedicle screw fixation (FGPSF) and its further development, robot-assisted percutaneous pedicle screw fixation (RAPSF), are minimally invasive spinal surgery (MISS) techniques. FGPSF is a standard technique at our hospital, and RAPSF incorporating artificial intelligence has been performed at our hospital since October 2021. This study compared these 2 techniques and analyzed their differences, accuracy, and clinical outcomes based on our experiences. Methods: This study conducted a detailed analysis of screw accuracy and the clinical outcomes of 2 MISS techniques, FGPSF, and RAPSF. Screw accuracy was evaluated using the Gertzbein and Robbins scale, categorizing placements into grades A–E, with grades A and B considered clinically acceptable. Accuracy was assessed using postoperative computed tomography images for FGPSF and intraoperative O-arm scan images for RAPSF. Clinical outcomes were compared by examining parameters, such as hospitalization duration, C-reactive protein (CRP) normalization period, estimated blood loss (EBL), and preoperative/postoperative visual analogue scale (VAS) scores. Screw-related complications were reviewed. Independent image evaluations by nonparticipating spine specialists ensured objective and reliable assessments. Results: Both FGPSF and RAPSF demonstrated high rates of clinically acceptable screw placement, with minimal breaches that required no repositioning. The clinically acceptable rates of FGPSF and RAPSF were similar (99.17% and 99.19%, respectively). Both groups also demonstrated similar clinical outcomes. The CRP normalization period, EBL, and ΔVAS (preoperative—postoperative) scores revealed no statistically significant differences between FGPSF and RAPSF. Neither group experienced screw-related complications; however, the RAPSF group exhibited a statistically significant shorter hospital stay than the FGPSF group. Conclusion This study compared the accuracy and clinical outcomes of FGPSF and RAPSF. Both methods demonstrated no significant differences in accuracy or clinical outcomes. Spine surgeons selected between the 2 methods based on individual patient needs, and additional research is required to fully understand the practical advantages of each technique in the clinical field.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has affected all medical fields, including neurosurgery. Particularly, performing preoperative screening tests has become mandatory, potentially extending the time from admission to the emergency room and operating room, thus possibly affecting patients’ prognosis. This study aimed to determine the influence of COVID-19 screening time on patients’ postoperative prognosis. Methods: From September 10, 2020, to May 31, 2021, we retrospectively evaluated 54 patients with cerebral hemorrhage who underwent emergency surgery in the emergency room after the screening test. The control group included 89 patients with cerebral hemorrhage who underwent emergency surgery between January 2019 and March 2020, i.e., the period before the COVID-19 pandemic. Prognosis was measured using the Glasgow Coma Scale scores, which were obtained preoperatively, postoperatively, and at discharge, and the modified Rankin Scale (mRS). Additionally, unfavorable outcomes (mRS score 3–6) and in-hospital mortality rates were investigated for postoperative prognostic assessments. Results: No remarkable differences were observed in the time to surgical intervention and prognostic evaluation scores between patients with cerebral hemorrhage who underwent COVID-19 screening tests and subjects in the control group. Conclusion This study confirmed that patient treatment and prognosis were not significantly affected by additional preoperative screening testing times during the pandemic. We believe that our results are informative for the evaluation and performance of emergency neurosurgery during the pandemic.

Objective: : Vertebral artery dissecting aneurysm (VADA) is a very rare subtype of intracranial aneurysms; when ruptured, it is associated with significantly high rates of morbidity and mortality. Despite several discussions and debates, the optimal treatment for VADA has not yet been established. In the last 10 years, flow diverter devices (FDD) have emerged as a challenging and new treatment method, and various clinical and radiological results have been reported about their safety and effectiveness. The aim of our study was to evaluate the clinical and radiological results with the use of FDD in the treatment of unruptured VADA. Methods: : We retrospectively evaluated the data of all patients with unruptured VADA treated with FDD between January 2018 and February 2021 at our hybrid operating room. Nine patients with unruptured VADA, deemed hemodynamically unstable, were treated with FDD. Among other parameters, the technical feasibility of the procedure, procedure-related complications, angiographic results, and clinical outcomes were evaluated. Results: : Successful FDD deployment was achieved in all cases, and the immediate follow-up angiography showed intra-aneurysmal contrast stasis with parent artery preservation. A temporary episode of facial numbness and palsy was noted in one patient; however, the symptoms had completely disappeared when followed up at the outpatient clinic 2 weeks after the procedure. The 3–6 months follow-up angiography (n=9) demonstrated completeear-complete obliteration of the aneurysm in seven patients, and partial obliteration and segmental occlusion in one patient each. In the patient who achieved only partial obliteration, there was a sac 13 mm in size, and there was no change in the 1-year follow-up angiography. In the patient with segmental occlusion, the cause could not be determined. The clinical outcome was modified Rankin Scale 0 in all patients. Conclusion : Our preliminary study using FDD to treat hemodynamically unstable unruptured VADA showed that FDD is safe and effective. Our study has limitations in that the number of cases is small, and it is not a prospective study. However, we believe that the study contributes to evidence regarding the safety and effectiveness of FDD in the treatment of unruptured VADA.

Objective: Ventriculoatrial shunt (VAS) remains an alternate option for treatment of hydrocephalus in patients with ventriculoperitoneal shunt (VPS) failure. Unfamiliar anatomy for a neurosurgeon has resulted in the VAS falling out of favor as a treatment option. However, there are unsatisfactory reports on the long-term result of VPS, and VAS has been recently re-evaluated. We are to report the simple way to do the VAS using a peel-away sheath in a hybrid operation room. Methods: A jugular vein path was drawn by ultrasound, a small incision was made above the clavicle, and a shunt catheter was tunneled into it. The jugular vein was punctured beside the tunneled catheter with a Seldinger needle under ultrasound guidance. A flexible guide wire was introduced into the vein and 6-Fr peel-away sheath was advanced into the vein along the wire. Under fluoroscopic guidance, the catheter was cut to position approximately midlevel in the atrium. After the guide wire was removed, the distal shunt catheter was passed down. After confirming proper position of the distal catheter under the fluoroscope, the catheter-guiding sheath was pulled out as a peeling-away manner. We performed this surgical procedures in 5 cases. Results: All the procedures of the VAS using a peel-away sheath were performed in a hybrid operation room Of 5 patients, 3 patients had the distal catheter failures in the peritoneal cavity and 2 patients had shunt A distal catheter was successfully indwelling in all the cases without any difficulties. After the surgery, neither shunt infection nor thromboembolic event happened. Conclusion VAS using fluoroscopy and a peel-away sheath is a good alternative option for hydrocephalus patients with shunt failure related to peritoneal cavity complications.