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: 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: 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: Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program. Methods: K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation. Results: Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea. Conclusion This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.

Purpose: Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program. Methods: K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation. Results: Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea. Conclusion This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.

Purpose: Improvements in surgical quality and patient safety are critical components of the healthcare system. Despite excellent cancer survival rates in Korea, there is a lack of standardized postoperative complication management systems.To address this gap, the Korean Surgical Society initiated the development of the Korean Quality Improvement Platform in Surgery (K-QIPS) program. Methods: K-QIPS was successfully launched in 87 general hospitals. This nationwide surgical quality improvement program covers 5 major surgical fields: gastric surgery, colorectal surgery, hepatectomy and liver transplantation, pancreatectomy, and kidney transplantation. Results: Common and surgery-specific complication platforms will be developed, and the program will work toward the implementation of an artificial intelligence-based complication prediction system and the provision of evidence-based feedback to participating institutions. K-QIPS represents a significant step toward improving surgical quality and patient safety in Korea. Conclusion This program aims to reduce postoperative complications, mortality, and medical costs by providing a standardized platform for complication management and prediction. The successful implementation of this nationwide project may provide a good model for other countries that are required to improve surgical outcomes and patient care.

Purpose: Risk factors predicting distant metastasis (DM) in extrahepatic bile duct cancer (EHBDC) patients treated with curative resection were investigated. Materials and Methods: Medical records of 1,418 EHBDC patients undergoing curative resection between Jan 2000 and Dec 2015 from 14 institutions were reviewed. After resection, 924 patients (67.6%) were surveilled without adjuvant therapy, 297 (21.7%) were treated with concurrent chemoradiotherapy (CCRT) and 148 (10.8%) with CCRT followed by chemotherapy. To exclude the treatment effect from innate confounders, patients not treated with adjuvant therapy were evaluated. Results: After a median follow-up of 36.7 months (range, 2.7 to 213.2 months), the 5-year distant metastasis-free survival (DMFS) rate was 57.7%. On multivariate analysis, perihilar or diffuse tumor (hazard ratio [HR], 1.391; p=0.004), poorly differentiated histology (HR, 2.014; p < 0.001), presence of perineural invasion (HR, 1.768; p < 0.001), positive nodal metastasis (HR, 2.670; p < 0.001) and preoperative carbohydrate antigen (CA) 19-9 ≥ 37 U/mL (HR, 1.353; p < 0.001) were significantly associated with inferior DMFS. The DMFS rates significantly differed according to the number of these risk factors. For validation, patients who underwent adjuvant therapy were evaluated. In patients with ≥ 3 factors, additional chemotherapy after CCRT resulted in a superior DMFS compared with CCRT alone (5-year rate, 47.6% vs. 27.7%; p=0.001), but the benefit of additional chemotherapy was not observed in patients with 0-2 risk factors. Conclusion Tumor location, histologic differentiation, perineural invasion, lymph node metastasis, and preoperative CA 19-9 level predicted DM risk in resected EHBDC. These risk factors might help identifying a subset of patients who could benefit from additional chemotherapy after resection.