Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients. Materials and Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided. Results: From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient. Conclusion Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.

Purpose: Hematopoietic stem cell transplantation (HSCT) has been an important method of treatment in the advance of pediatric acute lymphoblastic leukemia (ALL). The indications for HSCT are evolving and require updated establishment. In this study, we aimed to investigate the efficacy of HSCT on the treatment outcome of pediatric ALL, considering the indications for HSCT and subgroups. Materials and Methods: A retrospective analysis was conducted on ALL patients diagnosed and treated at a single center. Risk groups were categorized based on age at diagnosis, initial white blood cell count, disease lineage (B/T), and cytogenetic study results. Data on the patients’ disease status at HSCT and indications of HSCT were collected. Indications for HSCT were categorized as upfront HSCT at 1st complete remission, relapse, and refractory disease. Results: Among the 549 screened patients, a total of 418 patients were included in the study; B-cell ALL (n=379) and T-cell ALL (T-ALL) (n=39). HSCT was conducted on a total of 106 patients (25.4%), with a higher frequency as upfront HSCT in higher-risk groups and specific cytogenetics. The overall survival (OS) was significantly better when done upfront than in relapsed or refractory state in T-ALL patients (p=0.002). The KMT2A-rearranged ALL patients showed superior event-free survival (p=0.002) and OS (p=0.022) when HSCT was done as upfront treatment. Conclusion HSCT had a substantial positive effect in a specific subset of pediatric ALL. In particular, frontline HSCT for T-ALL and KMT2A-rearranged ALL offered a better prognosis than when HSCT was conducted in a relapsed or refractory setting.

Background/Aims: Direct-acting antivirals (DAAs) effectively eradicate hepatitis C virus. This study investigated whether metabolic dysfunction influences the likelihood of fibrosis regression after DAA treatment in patients with chronic hepatitis C (CHC). Methods: This multicenter, retrospective study included 8,819 patients diagnosed with CHC who were treated with DAAs and achieved a sustained virological response (SVR) between January 2014 and December 2022. Fibrosis regression was defined as a 20% reduction in noninvasive surrogates for liver fibrosis, such as liver stiffness (LS) measured by vibration-controlled transient elastography (VCTE) and the fibrosis-4 (FIB-4) score. Hypercholesterolemia (h-TC) was defined as >200 mg/dL. Results: The median age of the study population was 59.6 years, with a predominance of male patients (n=4,713, 57.3%). Genotypes 1, 2, and others were confirmed in 3,872 (46.2%), 3,487 (41.6%), and 1,024 (12.2%) patients, respectively. Diabetes mellitus (DM) was present in 1,442 (17.2%) patients and the median LS was 7.50 kPa (interquartile range, 5.30–12.50). Multivariate analysis revealed that the presence of DM and pre-DAA h-TC were independently associated with a decreased probability of fibrosis regression by VCTE. Additionally, pre-DAA h-TC was independently associated with a decreased probability of fibrosis regression by the FIB-4. Conclusions Metabolic dysfunction has an unfavorable influence on fibrosis regression in patients with CHC who achieve SVR after DAA treatment.

Remimazolam is a novel benzodiazepine with unique pharmacokinetic and pharmacodynamic properties, making it an ideal candidate for sedation during endoscopic procedures. Distinguished by its rapid onset and short duration of action, remimazolam offers a safer and more efficient alternative to traditional sedatives, such as midazolam and propofol, with fewer side effects, such as hypotension, bradycardia, and respiratory depression. This article reviews the characteristics of remimazolam and its practical advantages, including ease of use, quick recovery time, and minimal residual sedation, emphasizing its potential to improve patient safety and procedural efficiency in clinical endoscopy settings.

Background: s/Aims: While large-for-size syndrome is uncommon in liver transplantation (LT), it can result in fatal outcome. To prevent such fatality, we manufactured 3D-printed intra-abdominal cavity replicas to provide intuitive understanding of the sizes of the graft and the patient’s abdomen in patients with small body size between July 2020 and February 2022. Methods: Clinical outcomes were compared between patients using our 3D model during LT, and patients who underwent LT without 3D model by using 1 : 5 ratio propensity score-matched analysis. Results: After matching, a total of 20 patients using 3D-printed abdominal cavity model and 100 patients of the control group were included in this study. There were no significant differences in 30-day postoperative complication (50.0% vs. 64.0%, p = 0.356) and the incidence of large-for-size syndrome (0% vs. 7%, p = 0.599). Overall survival of the 3D-printed group was similar to that of the control group (p = 0.665), but graft survival was significantly superior in the 3D-printed group, compared to the control group (p = 0.034). Conclusions Since it showed better graft survival, as well as low cost and short production time, our 3D-printing protocol can be a feasible option for patients with small abdominal cavity to prevent large-for-size syndrome after LT.

Purpose: This study aimed to evaluate current morbidity rates following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colorectal cancer and peritoneal metastasis. Methods: A total of 42 patients who underwent CRS and HIPEC for colorectal cancer with peritoneal metastasis at a single tertiary referral center between January 2022 and December 2022 were included. Perioperative outcomes and postoperative complications were prospectively assessed. Results: The mean peritoneal cancer index (PCI) was 16.0. The distribution of PCI scores was as follows: <10, 33.3%; 10– 19, 26.2%; and ≥ 20, 40.5%. Completeness of the cytoreduction (CCR) scores were as follows: 57.1% of patients achieved CCR-0, 16.7% achieved CCR-1, 7.1% achieved CCR-2, and 19.0% achieved CCR-3. The mean operation time was 9.1 hours, and the median hospital stay was 17.0 days. Postoperative complications occurred within 30 days in 47.6% of cases and between 30 and 60 days in 11.9% of cases. Reoperation within 30 days was required in 5 cases, and 1 patient died within 30 days. The most common complications were pleural effusion (5 patients), anastomosis site leakage (3 patients), and pneumonia (3 patients). Patients with higher PCI scores were more likely to experience complications (P = 0.038). Conclusion Although CRS and HIPEC are still associated with high morbidity and mortality compared to other colorectal surgeries, outcomes have improved with increased experience. These results suggest that the procedure is becoming a more acceptable treatment option over time.

Purpose: Common bile duct (CBD) stone recurrence after laparoscopic CBD exploration (LCBDE) is relatively common. No studies have been conducted evaluating the safety and feasibility of re-do LCBDE in the treatment of recurrent CBD stones. Methods: This single-center retrospective study reviewed 340 consecutive patients who underwent LCBDE for CBD stones between January 2004 and December 2020. Patients with pancreatobiliary malignancies and those who underwent other surgical procedures were excluded. Results: Of the 340 included patients, 45 experienced a recurrence after a mean follow-up period of 24.2 months. Of them, 18 underwent re-do LCBDE, 20 underwent endoscopic intervention, 2 underwent radiologic intervention, and 5 underwent observation. Re-do LCBDE and initial LCBDE showed similar surgical outcomes in terms of operative time (113.1 minutes vs. 107.5 minutes, P = 0.515), estimated blood loss (42.5 mL vs. 49.1 mL, P = 0.661), open conversion rate (2.9% vs. 0%, P = 0.461), postoperative complication (15.3% vs. 22.2%, P = 0.430), and postoperative hospital stay (6.5 days vs. 6.4 days, P = 0.921). Comparing re-do LCBDE and nonsurgical treatment (endoscopic or radiologic), no statistically significant differences were noted in posttreatment complication (22.2% vs. 13.6%, P = 0.477), hospital stay (6.4 days vs.7.3 days, P = 0.607), and recurrence (50.0% vs. 36.4%, P = 0.385). The clearance rate was higher in the re-do LCBDE group than in the nonsurgical group (100% vs. 81.8%, P = 0.057). Conclusion Compared to initial LCBDE and endoscopic or radiological treatments, re-do LCBDE for recurrent CBD stones is a treatment option worth considering in selected patients.

Background: The advantages of using an acellular dermal matrix (ADM) for implantbased breast reconstruction in breast cancer patients are well-documented across multiple studies. However, there have been no previous instances of using multilayered ADM for reconstruction following breast-conserving surgery (BCS). This study evaluated the outcomes of breast reconstruction employing multilayered ADM for volume replacement using a local glandular flap post-BCS, and aims to underscore the advantages of this surgical approach. Methods: Breast cancer patients who underwent BCS using several layers of ADM from August 2016 to December 2019 were retrospectively reviewed. Only patients with at least 3 years of follow-up were included in this study. The anticipated postoperative complications were breast deformity, seroma, hematoma, and infection. Results: Seventy-four patients were included in this study. Most patients experienced symptoms of hard palpation at the reconstruction site, which indicated the surface of the ADM inserted into the breast. Ten patients developed breast deformities, accounting for 13.5% of the cases, and required surgical correction. Other complications were less frequent: four patients (5.3%) had a confirmed seroma for 6 months or longer, two patients (2.6%) experienced fat necrosis, and one patient (1.3%) underwent re-operation to remove the ADM. Conclusions Reconstruction with a glandular flap and ADM following BCS is generally simpler and requires less surgical time compared to using a latissimus dorsi flap or other local flaps. Additionally, it avoids complications at the donor site, presenting a feasible surgical alternative for BCS in breasts with small defects.

Methods: The UBE approach targeted the ventral part of the superior articular process in the transforaminal UBE setup, specifically for upper lumbar disc herniation, with an approach angle of approximately 30º on the axial plane. Intraoperative navigation was employed to improve puncture accuracy for this relatively unfamiliar surgical technique. Navigation-assisted transforaminal UBE lumbar discectomy was performed on four patients presenting with back or leg discomfort due to disc herniation at the L1–L2 or L2–L3 levels. Results: All patients experienced symptom relief and were discharged on postoperative day 2. Conclusions Transforaminal UBE lumbar discectomy is a viable therapeutic option for upper lumbar paracentral disc herniation, which is typically associated with poor prognosis. Integrating navigation integration into this novel approach enhances precision and safety.

Purpose: To evaluate the differences in the level of concerns regarding exotropia surgery according to the perspectives regarding surgery and basic characteristics of parents of pediatric patients with intermittent exotropia in South Korea. Methods: This study included the parents of pediatric patients with intermittent exotropia who underwent surgery at five hospitals, between June 2022 and February 2023. Parental perspectives, basic characteristics, and levels of concern regarding surgery were assessed using a questionnaire. We investigated the differences in concern levels according to perspectives regarding surgery and basic characteristics among parents, such as sex, age, residential area, and the most influential factors in the decision-making for surgery. Results: A total of 266 parents were included (228 mothers; age, 40.0±4.7 years). Parents who chose surgery for subjective symptoms had higher levels of concern about hemorrhage, conjunctival redness, and persistent overcorrection than did those who chose surgery for cosmetic reasons (all p < 0.05). Fathers were more concerned about postoperative pain, compared to mothers (p = 0.039). Parents in their 40s and 50s had higher levels of concern about the hospital environment compared with those in their 20s and 30s (p = 0.003). Concern did not significantly differ by residential area. Conclusions The level of concern regarding surgery differed according to the perspectives and characteristics of the parents of pediatric patients with intermittent exotropia. Parents who chose surgery for subjective symptoms of exotropia had a higher level of concern than did those who chose surgery for cosmetic reasons. The concern level differed according to the parents’ sex and age but not their residential area.