1.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
2.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
3.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
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.
4.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
5.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
6.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
7.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
8.Feasibility and accuracy of pediatric core temperature measurement using an esophageal probe inserted through the gastric lumen of a second-generation supraglottic airway device: a prospective observational study
Yeon-Ju KIM ; Eundong LEE ; Jaedo LEE ; Hyungtae KIM ; Won Uk KOH ; Young-Jin RO ; Ha-Jung KIM
Anesthesia and Pain Medicine 2024;19(Suppl 1):S105-S112
Background:
Accurate core temperature measurement in children is crucial; however, measuring esophageal temperature (TE) using a supraglottic airway device (SAD) can be challenging. Second-generation SADs, which have a gastric channel, can measure TE, and reduce gastric air volume. This study aimed to compare TE, measured using a probe inserted through the SAD gastric channel, with tympanic membrane (TTM) and forehead (TZHF) temperatures, measured using a zero-heat-flux cutaneous thermometer, with rectal temperature (TR).
Methods:
Temperature was recorded at 10-min intervals from 10 min after probe insertion until completion of surgery. We performed an equivalence test to evaluate whether the TE, TTM, and TZHF were equivalent to TR, with a margin of 0.3°C. Additionally, intraclass correlation coefficients (ICC) were calculated to assess the reliability of TE and TR at each time point.
Results:
We included 41 patients in the final analysis. In all patients, the esophageal probe was successfully inserted through the gastric channel of the SAD. When assessing agreement with TR as a reference, TE demonstrated equivalent results at all time points (P < 0.001 at 0, 10, 20, 30, and 40-min intervals and P = 0.018 at the 50-min interval), except at the completion of surgery (P = 0.697). TE also demonstrated good reliability with TR as a reference throughout the surgery (ICC > 0.75).
Conclusions
In children with SAD insertion, TE can be accurately and feasibly measured through the SAD’s gastric channel, making it suitable for routine application.
9.Comparison of preemptive and preventive intravenous acetaminophen on opioid consumption in pediatrics undergoing posterior spinal fusion surgery: a randomized controlled trial
Yeon Ju KIM ; Ha-Jung KIM ; Sehee KIM ; Hyungtae KIM ; Choon Sung LEE ; Chang Ju HWANG ; Jae Hwan CHO ; Young-Jin RO ; Won Uk KOH
Korean Journal of Anesthesiology 2024;77(3):326-334
Background:
Posterior spinal fusion (PSF), commonly used for adolescent idiopathic scoliosis (AIS), causes severe postoperative pain. Intravenous (IV) administration of acetaminophen has shown promise for opioid-sparing analgesia; however, its analgesic effect and optimal timing for its standard use remain unclear. Our study aimed to evaluate the analgesic effect and optimal timing of IV acetaminophen administration in pediatric and adolescent patients undergoing PSF and requiring adequate pain control.
Methods:
This prospective, randomized, triple-blind trial was conducted in patients aged 11–20 undergoing PSF. Participants were randomized into three groups: the preemptive group (received IV acetaminophen 15 mg/kg after anesthetic induction/before surgical incision), the preventive group (received IV acetaminophen 15 mg/kg at the end of surgery/before skin closure), and the placebo group. The primary outcome was cumulative opioid consumption during the first 24 h postoperatively.
Results:
Among the 99 enrolled patients, the mean ± standard deviation (SD) amount of opioid consumption during the postoperative 24 h was 60.66 ± 23.84, 52.23 ± 22.43, and 66.70 ± 23.01 mg in the preemptive, preventive, and placebo groups, respectively (overall P = 0.043). A post hoc analysis revealed that the preventive group had significantly lower opioid consumption than the placebo group (P = 0.013). However, no significant differences between the groups were observed for the secondary outcomes.
Conclusions
The preventive administration of scheduled IV acetaminophen reduces cumulative opioid consumption without increasing the incidence of drug-induced adverse events in pediatric and adolescent patients undergoing PSF.
10.A novel kit for enrichment of fecal helminth eggs
Eunsol LEE ; Seon-Ok BACK ; Young-Ju LEE ; Jung-Won JU ; Hee-Il LEE ; Myoung-Ro LEE
Parasites, Hosts and Diseases 2024;62(3):323-329
We developed a new concentration kit, called the ParaEgg (PE), for easy detection trematode eggs from fecal samples in endemic areas of clonorchiasis and metagonimiasis in Korea. To create a standard of detection efficiency, 120 fecal samples were examined using the water–ether concentration method (WECM). The PE kit and Mini ParaSep (PS) kit were used to compare the detection sensitivity of 100 egg-positive and 20 egg-negative samples in WECM. Additionally, stool samples, which were intentionally spiked with 10, 20, and 30 Clonorchis sinensis eggs, were evaluated to assess the sensitivity in lowinfection cases. The PE and PS kits showed detection rates of 100% and 92%, respectively, from 100 egg-positive samples in WECM. Meanwhile, eggs were detected in 3 (PE) and 2 (PS) out of 20 egg-negative samples in WECM. The PE kit detected the highest number of eggs per gram of feces (727 on average), followed by the WECM (524) and PS kit (432). In fecal samples that were intentionally spiked with 10, 20, and 30 C. sinensis eggs, PE only detected eggs 2 out of 5 samples in 10 eggs spiked (40%), and the detection rates were 80% and 100%, respectively. The PE kit enabled a more accurate identification of trematode eggs because of the clearance of small fecal debris in the microscopic field. In conclusion, the PE kit is obviously helpful to detect and identify trematode eggs in stool examinations especially in endemic areas of clonorchiasis and metagonimiasis.

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