지원연구분야 ( 코드 ) E-3 과제번호 창의과제프로그램공개가능여부과제성격 ( 기초, 응용, 개발 ) 응용실용화대상여부실용화공개 ( 공개, 비공개 ) ( 국문 ) 조기위암으로위절제술을시행받은환자에서내과적만성질환에미치는 연구과제명 과제책임자 세부과제 총연구

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1 지원연구분야 ( 코드 ) E-3 과제번호 창의과제프로그램공개가능여부과제성격 ( 기초, 응용, 개발 ) 응용실용화대상여부실용화공개 ( 공개, 비공개 ) ( 국문 ) 조기위암으로위절제술을시행받은환자에서내과적만성질환에미치는 연구과제명 과제책임자 세부과제 총연구기간 연구기간및 연구비 ( 단위 : 천원 ) 영향 ( 영문 )influence of gastrectomy on medial chronic illness in patients with early gastric cancer 구분 1 2 소속폐암센터직위의사직 성명이희석전공호흡기내과 세부과제명 조기위암으로위절제술을시행받은환자에서 잠복결핵치료의필요성확인및결핵약제에 대한약동학검사의임상적용 조기위암환자에서위절제및문합술이당뇨, 고혈압의만성대사성질환에미치는영향연 구 2012 년 2 월 ~ 2014 년 12 월 ( 총 3 년 ) 구분연구기간계 참여연구원수 ( 단위 : 명, MY) 국립암센터 계 ~ , ,000 제 1 차 ~ , ,000 제 2 차 ~ , ,000 제 3 차 ~ , ,000 세부과제책임자 성명 소속 ( 직위 ) 전공 의학 이희석폐암센터 ( 호흡기 ( 의사직 ) 내과 ) 류근원 참여기업명칭전화 FAX 위암연구과 ( 책임연구원 ) 37 명 (6.8 MY) 의학 ( 외과 ) 기업부담금소계현금현물 기관고유연구사업관리규칙에따라본연구개발사업을성실히수행하였으며아래와같이최종보고서 를제출합니다 년 10 월 31 일 과제책임자이희석 ( 서명 )

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3 연구개발에따른기대성과 γ

4 색인어 국문 영문

5 Influence of gastrectomy on medical chronic illness in patients with early gastric cancer latent tuberculosis, tuberculosis, early gastric cancer, gastrectomy, interferon gamma assay, pharmacokinetic, HEE SEOK LEE I. Development of active tuberculosis from latent tuberculosis in patients with early gastric cancer who underwent gastrectomy The study compared patients with early gastric cancer (EGC) who underwent gastrectomy(gastrectomy group) with those with EGC who underwent endoscopic submucosal dissection (control group). After being diagnosed with latent tuberculosis in each group via commercial interferon-γ assay (IGRA) the patients in each group were followed to identify whether they had active tuberculosis. From February 2012 to October , 584 patients with EGC in total were enrolled in the study. Among them, 339 of gastrectomy group and 188 of control group underwent IGRA. The test results said that the diagnosis rate of latent tuberculosis in each group turned out 47.8% and 46.3%, respectively, which refers to no significant difference between the two groups regarding the rate (P=0.568). It is assumed that low number of patients enrolled to the study and short follow-up period contributed to no active tuberculosis. Thus, the study needs to be continued. II. Pharmacokinetic characteristics of anti-tuberculous drugs in gastrectomized patients As active tuberculosis was found at our hospital, pharmacokinetic testing was implemented to 15 of gastrectomy group and 10 of control group, to whom the first-line TB drugs (HREZ) had been administered. As for Rifampin, Tmax was significantly extended in gastrectomy group(p=0.005), that also showed lower value in Cmax (P=0.055). In pyrazinamide, the gastrectomy group had significantly low value in AUC last (P=0.021). The study found for the first time that the treatment group had difficulties in absorbing anti-tuberculous drugs. III. Delayed response to anti-tuberculous treatment in gastrectomized patients The patients with pulmonary TB which was drug susceptible at our hospital, were divided into gastrectomy and control groups. Each group was set to receive treatment for a certain period of time (6mo vs 9 mo), respectively. Before the end of the period, lesions would be evaluated through LDCT. In case that more than 50% of the lesions disappear, treatment would stop. If more than 50% lesions remain, the treatment period would be extended to more than three months, depending on the patient s condition. Among 35 pulmonary TB patients, 16 and 19 were categorized into gastrectomy and control groups. Eight(50%) out of 16 in treatment group showed delayed response to the treatment during the designated period so their treatment was extended. In control group, 4(21.1%) out of 19 had extended period of the treatment(p=0.072). The results illustrated for the first time that the treatment group had delayed response to the treatment. Statistically significant outcome is expected as more patients will be registered to the study by next year.

6 IV. Influence of gastrectomy on chronic metabolic diseases Gastric cancer is the one of the leading cause of cancer death in the world including Korea. The survival of gastric cancer patients is improved as the increase of early gastric cancer (EGC) patients proportion by screening program in Korea. As the long term survivors increased, the improved quality of life (QOL) is essential problem in these patients. One of the factor impairing the QOL in these patients is the chronic metabolic disease like diabetes mellitus (DM) and hypertension which are the also a health problem in the world. However, studies about the effect of gastrectomy on the DM and hypertension are few and most of them are retrospective fashion with small number of patients. In this study, the EGC patients with gastrectomy was compared patients with endoscopic submucosal dissection (ESD) patients as for the control group. The gastrectomy was divied as total, subtotal with gastroduodenostomy, subtotal with loop gastrojejunostomy and subtotal with Roux-en Y gastrojejunostomy group. Each group is planned for 30 patients and the DM and hypertension data was collected at preoperately, 3 month and 1 year later after surgery. The enrolled patients was 142 but 65 patients were dropped out due to the reason of preference to local hospital and long distance from national cancer center. However, the analysis was done in avalable patients even in small number of patients in each subgroup. In DM patients the blood sugar was decreased in ESD and gastrectomy patients in 3 months but the ESD patient showed impaired as time goes on. The body weight was significantly decreased in gastrectomy group and the gastrointestinal hormonal change was not observed. In hypertension patients, body weight and blood pressure were significantly improved in gastrectomy patients in 3 months. The oral intake measured by diet diary showed no difference between ESD and gastrectomy patients even the body weight was significantly decreased in gastrectomy group. The the more data of completely enrolled patients are needed for analysis. In conclution, the DM and hypertension are impred in short term period after the gastrecomy in EGC patients.

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9 mean ± SD * Wilcoxon Two-sample test

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18 Following the natural course of diabetes and hypertension after surgery in gastric cancer patients: A retrospective Retrospective Nationwide Cohort Study nationwide cohort study Following the Natural Course of Diabetes and Hypertension after Surgery in Gastric Cancer Patients: A Korea Gastric International Cancer (KINGCA) Week 2014

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25 지원연구분야 ( 코드 ) E-3 과제번호 창의과제프로그램공개가능여부과제성격 ( 기초, 응용, 개발 ) 응용실용화대상여부실용화공개 ( 공개, 비공개 ) ( 국문 ) 조기위암으로위절제술을시행받은환자에서내과적만성질환에미치는 연구과제명 과제책임자 영향 ( 영문 )influence of gastrectomy on medial chronic illness in patients with early gastric cancer 구분 소속폐암센터직위의사직 성명이희석전공호흡기내과 세부과제명 세부과제책임자 성명 소속 ( 직위 ) 전공 세부과제 1 조기위암으로위절제술을시행받은환자에서 잠복결핵치료의필요성확인및결핵약제에 대한약동학검사의임상적용 이희석 폐암센터 ( 의사직 ) 의학 ( 호흡기 내과 ) 총연구기간 2012 년 2 월 ~ 2014 년 12 월 ( 총 3 년 ) 참여연구원수 ( 단위 : 명, MY) 16 명 (5.15 MY) 연구기간및 연구비 ( 단위 : 천원 ) 구분연구기간계 국립암센터 계 ~ , ,000 제 1 차 ~ ,000 50,000 제 2 차 ~ ,000 50,000 제 3 차 ~ ,000 50,000 참여기업명칭전화 FAX 기업부담금소계현금현물 기관고유연구사업관리규칙에따라본연구개발사업을성실히수행하였으며아래와같이최종보고서 를제출합니다 년 10 월 31 일 과제책임자이희석 ( 서명 )

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27 γ γ l l

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29 I. Development of active tuberculosis from latent tuberculosis in patients with early gastric cancer who underwent gastrectomy II. Pharmacokinetic characteristics of anti-tuberculous drugs in gastrectomized patients III. Delayed response to anti-tuberculous treatment in gastrectomized patients latent tuberculosis, tuberculosis, early gastric cancer, gastrectomy, interferon gamma assay, pharmacokinetic HEE SEOK LEE I. Development of active tuberculosis from latent tuberculosis in patients with early gastric cancer who underwent gastrectomy The study compared patients with early gastric cancer (EGC) who underwent gastrectomy(gastrectomy group) with those with EGC who underwent endoscopic submucosal dissection (control group). After being diagnosed with latent tuberculosis in each group via commercial interferon-γ assay (IGRA) the patients in each group were followed to identify whether they had active tuberculosis. From February 2012 to October , 584 patients with EGC in total were enrolled in the study. Among them, 339 of gastrectomy group and 188 of control group underwent IGRA. The test results said that the diagnosis rate of latent tuberculosis in each group turned out 47.8% and 46.3%, respectively, which refers to no significant difference between the two groups regarding the rate (P=0.568). It is assumed that low number of patients enrolled to the study and short follow-up period contributed to no active tuberculosis. Thus, the study needs to be continued. II. Pharmacokinetic characteristics of anti-tuberculous drugs in gastrectomized patients As active tuberculosis was found at our hospital, pharmacokinetic testing was implemented to 15 of gastrectomy group and 10 of control group, to whom the first-line TB drugs (HREZ) had been administered. As for Rifampin, Tmax was significantly extended in gastrectomy group(p=0.005), that also showed lower value in Cmax (P=0.055). In pyrazinamide, the gastrectomy group had significantly low value in AUC last (P=0.021). The study found for the first time that the treatment group had difficulties in absorbing anti-tuberculous drugs. III. Delayed response to anti-tuberculous treatment in gastrectomized patients The patients with pulmonary TB which was drug susceptible at our hospital, were divided into gastrectomy and control groups. Each group was set to receive treatment for a certain period of time (6mo vs 9 mo), respectively. Before the end of the period, lesions would be evaluated through LDCT. In case that more than 50% of the lesions disappear, treatment would stop. If more than 50% lesions remain, the treatment period would be extended to more than three months, depending on the patient s condition. Among 35 pulmonary TB patients, 16 and 19 were categorized into gastrectomy and control groups. Eight(50%) out of 16 in treatment group showed delayed response to the treatment during the designated period so their treatment was extended. In control group, 4(21.1%) out of 19 had extended period of the treatment(p=0.072). The results illustrated for the first time that the treatment group had delayed response to the treatment. Statistically significant outcome is expected as more patients will be registered to the study by next year.

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41 지원연구분야 ( 코드 ) LC0202 과제번호 창의과제프로그램공개가능여부과제성격 ( 기초, 응용, 개발 ) 응용실용화대상여부실용화공개 ( 공개, 비공개 ) ( 국문 ) 조기위암으로위절제술을시행받은환자에서내과적만성질환에미치 연구과제명 과제책임자 세부과제 는영향 ( 영문 ) Influence of gastrectomy on medical chronic illness in patients with early gastric cancer 구분 소속폐암센터직위의사직 성명이희석전공호흡기내과 세부과제명 세부과제책임자 성명 소속 ( 직위 ) 전공 총연구기간 참여연구원수 ( 단위 : 명, MY) 연구기간및 연구비 ( 단위 : 천원 ) 구분연구기간계 계 제 1 차 제 2 차 제 3 차 국립암센터 참여기업명칭전화 FAX 기업부담금소계현금현물 기관고유연구사업관리규칙에따라본연구개발사업을성실히수행하였으며아래와같이최종보고서 를제출합니다 년 10 월 30 일 과제책임자류근원 ( 서명 )

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43 연구목표 (200 자이내 ) 연구내용및방법 (500 자이내 ) < 최종목표 > < 당해연도목표 >

44 연구개발에따른기대성과 국문 조기위암위절제술내시경절제술 당뇨고혈압만성대사성질환 색인어 EGC Gastrectomy ESD 영문 DM Hypertension Chronic disease metabolic

45 Influence of gastrectomy on medical chronic illness in patients with early gastric cancer Gastric cancer is the one of the leading cause of cancer death in the world including Korea. The survival of gastric cancer patients is improved as the increase of early gastric cancer (EGC) patients proportion by screening program in Korea. As the long term survivors increased, the improved quality of life (QOL) is essential problem in these patients. One of the factor impairing the QOL in these patients is the chronic metabolic disease like diabetes mellitus (DM) and hypertension which are the also a health problem in the world. However, studies about the effect of gastrectomy on the DM and hypertension are few and most of them are retrospective fashion with small number of patients. In this study, the EGC patients with gastrectomy was compared patients with endoscopic submucosal dissection (ESD) patients as for the control group. The gastrectomy was divied as total, subtotal with gastroduodenostomy, subtotal with loop gastrojejunostomy and subtotal with Roux-en Y gastrojejunostomy group. Each group is planned for 30 patients and the DM and hypertension data was collected at preoperately, 3 month and 1 year later after surgery. The enrolled patients was 142 but 65 patients were dropped out due to the reason of preference to local hospital and long distance from national cancer center. However, the analysis was done in avalable patients even in small number of patients in each subgroup. In DM patients the blood sugar was decreased in ESD and gastrectomy patients in 3 months but the ESD patient showed impaired as time goes on. The body weight was significantly decreased in gastrectomy group and the gastrointestinal hormonal change was not observed. In hypertension patients, body weight and blood pressure were significantly improved in gastrectomy patients in 3 months. The oral intake measured by diet diary showed no difference between ESD and gastrectomy patients even the body weight was significantly decreased in gastrectomy group. The the more data of completely enrolled patients are needed for analysis. In conclution, the DM and hypertension are impred in short term period after the gastrecomy in EGC patients.

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52 Retrospective Nationwide Cohort Study Following the natural course of diabetes and hypertension after surgery in gastric cancer patients: A retrospective nationwide cohort study Following the Natural Course of Diabetes and Hypertension after Surgery in Gastric Cancer Patients: A Korea Gastric International Cancer (KINGCA) Week 2014

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- i - - ii - - iii - - iv - - v - - vi - - 1 - - 2 - - 3 - 1) 통계청고시제 2010-150 호 (2010.7.6 개정, 2011.1.1 시행 ) - 4 - 요양급여의적용기준및방법에관한세부사항에따른골밀도검사기준 (2007 년 11 월 1 일시행 ) - 5 - - 6 - - 7 - - 8 - - 9 - - 10 -

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