1.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
Background:
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods:
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
2.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
Background:
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods:
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
3.Perioperative nutritional practice of surgeons in Korea: a survey study
Ji-Hyeon PARK ; Mi Ran JUNG ; Sang Hyun KIM ; Hongbeom KIM ; Gyeongsil LEE ; Jae-Seok MIN ; Heung-Kwon OH ; Jung Hoon BAE ; Yoona CHUNG ; Dong-Seok HAN ; Seung Wan RYU ;
Annals of Clinical Nutrition and Metabolism 2024;16(3):134-148
Purpose:
Enhanced recovery after surgery (ERAS) protocols advocate reduced fasting and early nutrition to improve recovery in surgical patients. However, data on ERAS implementation among Korean surgeons performing major abdominal surgeries remain sparse.
Methods:
A survey conducted by the External Relation Committee of the Korean Society of Surgical Metabolism and Nutrition assessed perioperative nutritional practices among 389 Korean general surgeons from February to September 2023. The survey covered preoperative fasting, carbohydrate drinks, nasogastric tube use, postoperative dietary progression, parenteral nutrition (PN), and oral supplements, yielding 551 responses stratified by specialty.
Results:
More than 80% of respondents practiced “midnight NPO (Nil Per Os)” fasting, often at the anesthesiology department’s request, while 70%–80% reported no use of preoperative carbohydrate drinks. Most surgeons began dietary progression with water on postoperative day one, advancing to a liquid or soft diet by day two. PN was routinely prescribed by 49% of respondents, with a common dosage of 1,000–1,500 kcal/d. Oral supplements were selectively provided, with 21% of surgeons prescribing them universally.
Conclusion
The results reveal significant variability in perioperative nutrition practices across Korean surgical specialties, with many adhering to traditional practices despite ERAS guidelines. These findings highlight a need for standardized guidelines in Korea to optimize perioperative nutritional support and improve patient recovery outcomes following major abdominal surgeries.
4.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
Background:
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods:
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
5.Perioperative nutritional practice of surgeons in Korea: a survey study
Ji-Hyeon PARK ; Mi Ran JUNG ; Sang Hyun KIM ; Hongbeom KIM ; Gyeongsil LEE ; Jae-Seok MIN ; Heung-Kwon OH ; Jung Hoon BAE ; Yoona CHUNG ; Dong-Seok HAN ; Seung Wan RYU ;
Annals of Clinical Nutrition and Metabolism 2024;16(3):134-148
Purpose:
Enhanced recovery after surgery (ERAS) protocols advocate reduced fasting and early nutrition to improve recovery in surgical patients. However, data on ERAS implementation among Korean surgeons performing major abdominal surgeries remain sparse.
Methods:
A survey conducted by the External Relation Committee of the Korean Society of Surgical Metabolism and Nutrition assessed perioperative nutritional practices among 389 Korean general surgeons from February to September 2023. The survey covered preoperative fasting, carbohydrate drinks, nasogastric tube use, postoperative dietary progression, parenteral nutrition (PN), and oral supplements, yielding 551 responses stratified by specialty.
Results:
More than 80% of respondents practiced “midnight NPO (Nil Per Os)” fasting, often at the anesthesiology department’s request, while 70%–80% reported no use of preoperative carbohydrate drinks. Most surgeons began dietary progression with water on postoperative day one, advancing to a liquid or soft diet by day two. PN was routinely prescribed by 49% of respondents, with a common dosage of 1,000–1,500 kcal/d. Oral supplements were selectively provided, with 21% of surgeons prescribing them universally.
Conclusion
The results reveal significant variability in perioperative nutrition practices across Korean surgical specialties, with many adhering to traditional practices despite ERAS guidelines. These findings highlight a need for standardized guidelines in Korea to optimize perioperative nutritional support and improve patient recovery outcomes following major abdominal surgeries.
6.Perioperative nutritional practice of surgeons in Korea: a survey study
Ji-Hyeon PARK ; Mi Ran JUNG ; Sang Hyun KIM ; Hongbeom KIM ; Gyeongsil LEE ; Jae-Seok MIN ; Heung-Kwon OH ; Jung Hoon BAE ; Yoona CHUNG ; Dong-Seok HAN ; Seung Wan RYU ;
Annals of Clinical Nutrition and Metabolism 2024;16(3):134-148
Purpose:
Enhanced recovery after surgery (ERAS) protocols advocate reduced fasting and early nutrition to improve recovery in surgical patients. However, data on ERAS implementation among Korean surgeons performing major abdominal surgeries remain sparse.
Methods:
A survey conducted by the External Relation Committee of the Korean Society of Surgical Metabolism and Nutrition assessed perioperative nutritional practices among 389 Korean general surgeons from February to September 2023. The survey covered preoperative fasting, carbohydrate drinks, nasogastric tube use, postoperative dietary progression, parenteral nutrition (PN), and oral supplements, yielding 551 responses stratified by specialty.
Results:
More than 80% of respondents practiced “midnight NPO (Nil Per Os)” fasting, often at the anesthesiology department’s request, while 70%–80% reported no use of preoperative carbohydrate drinks. Most surgeons began dietary progression with water on postoperative day one, advancing to a liquid or soft diet by day two. PN was routinely prescribed by 49% of respondents, with a common dosage of 1,000–1,500 kcal/d. Oral supplements were selectively provided, with 21% of surgeons prescribing them universally.
Conclusion
The results reveal significant variability in perioperative nutrition practices across Korean surgical specialties, with many adhering to traditional practices despite ERAS guidelines. These findings highlight a need for standardized guidelines in Korea to optimize perioperative nutritional support and improve patient recovery outcomes following major abdominal surgeries.
7.Perioperative nutritional practice of surgeons in Korea: a survey study
Ji-Hyeon PARK ; Mi Ran JUNG ; Sang Hyun KIM ; Hongbeom KIM ; Gyeongsil LEE ; Jae-Seok MIN ; Heung-Kwon OH ; Jung Hoon BAE ; Yoona CHUNG ; Dong-Seok HAN ; Seung Wan RYU ;
Annals of Clinical Nutrition and Metabolism 2024;16(3):134-148
Purpose:
Enhanced recovery after surgery (ERAS) protocols advocate reduced fasting and early nutrition to improve recovery in surgical patients. However, data on ERAS implementation among Korean surgeons performing major abdominal surgeries remain sparse.
Methods:
A survey conducted by the External Relation Committee of the Korean Society of Surgical Metabolism and Nutrition assessed perioperative nutritional practices among 389 Korean general surgeons from February to September 2023. The survey covered preoperative fasting, carbohydrate drinks, nasogastric tube use, postoperative dietary progression, parenteral nutrition (PN), and oral supplements, yielding 551 responses stratified by specialty.
Results:
More than 80% of respondents practiced “midnight NPO (Nil Per Os)” fasting, often at the anesthesiology department’s request, while 70%–80% reported no use of preoperative carbohydrate drinks. Most surgeons began dietary progression with water on postoperative day one, advancing to a liquid or soft diet by day two. PN was routinely prescribed by 49% of respondents, with a common dosage of 1,000–1,500 kcal/d. Oral supplements were selectively provided, with 21% of surgeons prescribing them universally.
Conclusion
The results reveal significant variability in perioperative nutrition practices across Korean surgical specialties, with many adhering to traditional practices despite ERAS guidelines. These findings highlight a need for standardized guidelines in Korea to optimize perioperative nutritional support and improve patient recovery outcomes following major abdominal surgeries.
8.Perioperative nutritional practice of surgeons in Korea: a survey study
Ji-Hyeon PARK ; Mi Ran JUNG ; Sang Hyun KIM ; Hongbeom KIM ; Gyeongsil LEE ; Jae-Seok MIN ; Heung-Kwon OH ; Jung Hoon BAE ; Yoona CHUNG ; Dong-Seok HAN ; Seung Wan RYU ;
Annals of Clinical Nutrition and Metabolism 2024;16(3):134-148
Purpose:
Enhanced recovery after surgery (ERAS) protocols advocate reduced fasting and early nutrition to improve recovery in surgical patients. However, data on ERAS implementation among Korean surgeons performing major abdominal surgeries remain sparse.
Methods:
A survey conducted by the External Relation Committee of the Korean Society of Surgical Metabolism and Nutrition assessed perioperative nutritional practices among 389 Korean general surgeons from February to September 2023. The survey covered preoperative fasting, carbohydrate drinks, nasogastric tube use, postoperative dietary progression, parenteral nutrition (PN), and oral supplements, yielding 551 responses stratified by specialty.
Results:
More than 80% of respondents practiced “midnight NPO (Nil Per Os)” fasting, often at the anesthesiology department’s request, while 70%–80% reported no use of preoperative carbohydrate drinks. Most surgeons began dietary progression with water on postoperative day one, advancing to a liquid or soft diet by day two. PN was routinely prescribed by 49% of respondents, with a common dosage of 1,000–1,500 kcal/d. Oral supplements were selectively provided, with 21% of surgeons prescribing them universally.
Conclusion
The results reveal significant variability in perioperative nutrition practices across Korean surgical specialties, with many adhering to traditional practices despite ERAS guidelines. These findings highlight a need for standardized guidelines in Korea to optimize perioperative nutritional support and improve patient recovery outcomes following major abdominal surgeries.
9.Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea
Byung-Joon KIM ; Jun-Seop SHIN ; Byoung-Hoon MIN ; Jong-Min KIM ; Chung-Gyu PARK ; Hee-Jung KANG ; Eung Soo HWANG ; Won-Woo LEE ; Jung-Sik KIM ; Hyun Je KIM ; Iov KWON ; Jae Sung KIM ; Geun Soo KIM ; Joonho MOON ; Du Yeon SHIN ; Bumrae CHO ; Heung-Mo YANG ; Sung Joo KIM ; Kwang-Won KIM
Diabetes & Metabolism Journal 2024;48(6):1160-1168
Background:
Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans.
Methods:
A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness.
Conclusion
A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.
10.Microbiologic pattern and clinical outcome of non-ICU-acquired pneumonia: Korean HAP registry analysis
Jin Ho JANG ; Hye Ju YEO ; Taehwa KIM ; Woo Hyun CHO ; Kyung Hoon MIN ; Sang-Bum HONG ; Ae-Rin BAEK ; Hyun-Kyung LEE ; Changhwan KIM ; Youjin CHANG ; Hye Kyeong PARK ; Jee Youn OH ; Heung Bum LEE ; Soohyun BAE ; Jae Young MOON ; Kwang Ha YOO ; Hyun-Il GIL ; Kyeongman JEON ;
The Korean Journal of Internal Medicine 2023;38(3):450-450

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