Collaborative study for surgical quality improvement between NCD and ACS-NSQIP

• Project/Area Number: 16K10437
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: General surgery
• Research Institution: Osaka General Medical Center (2018-2019); Fukushima Medical University (2016-2017)
• Principal Investigator: Gotoh Mitsukazu 地方独立行政法人大阪府立病院機構大阪急性期・総合医療センター(臨床研究支援センター), 大阪急性期・総合医療センター 総長, 総長 (50162160)
• Co-Investigator(Kenkyū-buntansha): 丸橋 繁 福島県立医科大学, 医学部, 教授 (20362725)
• Project Period (FY): 2016-04-01 – 2020-03-31
• Project Status: Completed (Fiscal Year 2019)
• Budget Amount: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000); Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000); Fiscal Year 2017: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000); Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
• Keywords: 医療の質の評価 / リスクモデル / 消化器外科 / 医療水準評価術式 / 術後合併症 / ACS-NSQIP / NCD / risk calculator

Outline of Final Research Achievements

The Japanese Society of Gastroenterological Surgery (JSGS) and the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) have collaboratively developed several clinical projects since 2011 using two nationwide clinical registries with the goal of achieving further improvement of surgical quality in both countries. In this study we have carried out joint projects on 1) the Morbidity-Mortality Study and 2) Cross-national validation study of the ACS NSQIP Risk Calculator. In Morbidity-Mortality Study, postoperative morbidities rather than preoperative comorbidities were responsible for mortality in two major procedures including hepatectomy and pancreaticoduodenectomy. In the calibration study for low anterior resection a lack of calibration with different event rates were improved by simple method of intercept correction, suggesting as a general strategy for cross-national validation of the risk calculator.

Academic Significance and Societal Importance of the Research Achievements

わが国と米国では、手術成績に関わる多くの因子が異なると思われる。年齢構成、健康に関わるライフスタイル（肥満やダイエット等）、手術そのもの、あるいは合併症が起きたときの対応や保険制度等も異なる。その中で、術後死亡に強く関わる因子は、術前因子よりも術後合併症の発生であることが明確になった。また、NSQIPのrisk calculatorではわが国の死亡イベントを高く予測した。この傾向は2011、2012年の集計結果（Medicine (Baltimore). 2015 Dec;94(49):e2194）でも観察されており、それを説明する原因因子の解析は今後の課題となった。

Research Products

• [Int'l Joint Research] ACS-NSQIP(米国)
• [Int'l Joint Research] ACS-NSQIP(米国)
• [Int'l Joint Research] ACS-NSQIP(米国)
• [Journal Article] Initial verification of data from a clinical database of gastroenterological surgery in Japan. (2019)
  • Author(s): Kanaji S, Takahashi A, Miyata H, Marubashi S, Kakeji Y, Konno H, Gotoh M,
  • Journal Title: Surg Today Volume: 49 Pages: 328-351
  • Peer Reviewed
• [Journal Article] Surgical quality improvement programs in Japan and USA: Report from the collaborative projects between Japanese Society of Gastroenterological Surgery and American College of Surgeons National Surgical Quality Improvement Program (2019)
  • Author(s): Marubashi Shigeru、Liu Jessica Y.、Miyata Hiroaki、Cohen Mark E.、Ko Clifford Y.、Seto Yasuyuki、Gotoh Mitsukazu
  • Journal Title: Annals of Gastroenterological Surgery Volume: 3 Issue: 4 Pages: 343-351
  • DOI: 10.1002/ags3.12250
  • Peer Reviewed / Open Access
• [Journal Article] Risk calculator for predicting postoperative pneumonia after gastroenterological surgery based on a national Japanese database (2019)
  • Author(s): Takesue Y, Miyata H, Gotoh M, Wakabayashi G, Konno H, Mori M, Kumamaru H, Ueda T, Nakajima K, Uchino M, Seto Y
  • Journal Title: Annals of Gastroenterological Surgery Volume: －
  • Peer Reviewed
• [Journal Article] Surgical quality improvement programs in Japan and United States. A from the collaborative projects between NCD and ACS-NSQIP (2019)
  • Author(s): Marubashi S, Liu JY, Ko CY, Miyata H, Cohen ME, Gotoh M
  • Journal Title: Annals of Gastroenterological Surgery Volume: －
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Significance of the board-certified surgeon systems and clinical practice guideline adherence to surgical treatment of esophageal cancer in Japan: a questionnaire survey of departments registered in the National Clinical Database (2019)
  • Author(s): Toh Yasushi、Yamamoto Hiroyuki、Miyata Hiroaki、Gotoh Mitsukazu、Watanabe Masayuki、Matsubara Hisahiro、Kakeji Yoshihiro、Seto Yasuyuki
  • Journal Title: Esophagus Volume: － Issue: 4 Pages: 362-370
  • DOI: 10.1007/s10388-019-00672-1
  • Peer Reviewed / Open Access
• [Journal Article] Risk assessment of morbidities after right hemicolectomy based on the National Clinical Database in Japan (2018)
  • Author(s): Yoshida Takahiro, Miyata Hiroaki, Konno Hiroyuki, Kumamaru Hiraku, Tangoku Akira, Furukita Yoshihito, Hirahara Norimichi, Wakabayashi Go, Gotoh Mitsukazu, Mori Masaki
  • Journal Title: Annals of Gastroenterological Surgery Volume: 2 Issue: 3 Pages: 220-230
  • DOI: 10.1002/ags3.12067
  • Peer Reviewed / Open Access
• [Journal Article] Initial verification of data from a clinical database of gastroenterological surgery in Japan (2018)
  • Author(s): Kanaji Shingo, Takahashi Arata, Miyata Hiroaki, Marubashi Shigeru, Kakeji Yoshihiro, Konno Hiroyuki, Gotoh Mitsukazu, Seto Yasuyuki
  • Journal Title: Surgery Today Volume: 49 Issue: 4 Pages: 328-333
  • DOI: 10.1007/s00595-018-1733-9
  • Peer Reviewed
• [Journal Article] Current status of projects for developing cancer-related clinical practice guidelines in Japan and recommendations for the future (2018)
  • Author(s): Imamura Masafumi,Hirata Koichi,Unno Michiaki,Kamiya Kinj,Gotoh Mitsukazu,Konno Hiroyuki,Shibata Akiko,Sugihara Kenichi,Takahashi Arata,Nishiyama Masahiko,Hakamada Kenichi,Fukui Tsuguya,Furukawa Toshiharu,Mizushima Tsunekazu,Mizuma Masamichi,Miyata Hiroaki,Mori Masaki,Takemasa Ichiro,Mizuguchi Toru,Fujiwara Toshiyoshi
  • Journal Title: International Journal of Clinical Oncology Volume: 24 Issue: 2 Pages: 189-195
  • DOI: 10.1007/s10147-018-1340-1
  • Peer Reviewed / Open Access
• [Journal Article] “Real-time” risk models of postoperative morbidity and mortality for liver transplants (2018)
  • Author(s): Marubashi Shigeru, Ichihara Naoaki, Kakeji Yoshihiro, Miyata Hiroaki, Taketomi Akinobu, Egawa Hiroto, Takada Yasutsugu, Umeshita Koji, Seto Yasuyuki, Gotoh Mitsukazu
  • Journal Title: Annals of Gastroenterological Surgery Volume: 3 Issue: 1 Pages: 75-95
  • DOI: 10.1002/ags3.12217
  • Peer Reviewed / Open Access
• [Journal Article] Development and external validation of preoperative risk models for operative morbidities after total gastrectomy using a Japanese web-based nationwide registry. (2017)
  • Author(s): Kikuchi H, Miyata H, Konno H, Kamiya K, Tomotaki A, Gotoh M, Wakabayashi G, Mori M.
  • Journal Title: Gastric Cancer Volume: 20(6) Issue: 6 Pages: 987-997
  • DOI: 10.1007/s10120-017-0706-9
  • Peer Reviewed / Open Access
• [Journal Article] Prediction model for complications after low anterior resection based on data from 33,411 Japanese patients included in the National Clinical Database. (2017)
  • Author(s): Watanabe T, Miyata H, Konno H, Kawai K, Ishihara S, Sunami E, Hirahara N, Wakabayashi G, Gotoh M, Mori M.
  • Journal Title: Surgery Volume: 印刷中 Issue: 6 Pages: 1597-1608
  • DOI: 10.1016/j.surg.2016.12.011
  • Peer Reviewed / Open Access
• [Journal Article] Modeling preoperative risk factors for potentially lethal morbidities using a nationwide Japanese web-based database of patients undergoing distal gastrectomy for gastric cancer (2017)
  • Author(s): Kunisaki C, Miyata H, Konno H, Saze Z, Hirahara N, Kikuchi H, Wakabayashi G, Gotoh M, Mori M.
  • Journal Title: Gastric Cancer Volume: 20(3) Issue: 3 Pages: 496-507
  • DOI: 10.1007/s10120-016-0634-0
  • Peer Reviewed / Open Access
• [Journal Article] Risk factors of serious postoperative complications after pancreaticoduodenectomy and risk calculators for predicting postoperative complications: a nationwide study of 17,564 patients in Japan (2017)
  • Author(s): Aoki S, Miyata H, Konno H, Gotoh M, Motoi F, Kumamaru H, Wakabayashi G, Kakeji Y, Mori M, Seto Y, Unno M
  • Journal Title: J Hepatobiliary Pancreat Sci Volume: 24(5) Issue: 5 Pages: 243-251
  • DOI: 10.1002/jhbp.438
  • Peer Reviewed / Open Access
• [Journal Article] Association between the participation of board-certified surgeons in gastroenterological surgery and operative mortality after eight gastroenterological procedures (2017)
  • Author(s): Konno H, Kamiya K, Kikuchi H, Miyata H, Hirahara N, Gotoh M, Wakabayashi G, Ohta T, Kokudo N, Mori M, Seto Y
  • Journal Title: Surg Today Volume: 47(5) Issue: 5 Pages: 611-618
  • DOI: 10.1007/s00595-016-1422-5
  • Peer Reviewed
• [Journal Article] National Clinical Database(消化器外科領域) Annual Report 2015 (2017)
  • Author(s): 掛地吉弘, 宇田川晴司, 海野倫明, 遠藤 格, 國崎主税, 武冨紹信, 丹黒 章, 正木忠彦, 丸橋 繁, 吉田和弘, 渡邉聡明, 後藤満一, 今野弘之, 高橋 新, 宮田裕章, 瀬戸泰之, 一般社団法人National Clinical Database
  • Journal Title: 日本消化器外科学会雑誌 Volume: 50(2) Pages: 166-176
  • NAID: 130005242966
  • Open Access
• [Journal Article] Models predicting the risks of six life-threatening morbidities and bile leakage in 14,970 hepatectomy patients registered in the National Clinical Database of Japan. (2016)
  • Author(s): Yokoo H, Miyata H, Konno H, Taketomi A, Kakisaka T, Hirahara N, Wakabayashi G, Gotoh M, Mori M.
  • Journal Title: Medicine (Baltimore) Volume: 95 Issue: 49 Pages: e5466-e5466
  • DOI: 10.1097/md.0000000000005466
  • Peer Reviewed / Open Access
• [Journal Article] Comparison of laparoscopic major hepatectomy with propensity score matched open cases from the National Clinical Database in Japan. (2016)
  • Author(s): Takahara T, Wakabayashi G, Konno H, Gotoh M, Yamaue H, Yanaga K, Fujimoto J, Kaneko H, Unno M, Endo I, Seto Y, Miyata H, Miyazaki M, Yamamoto M.
  • Journal Title: J Hepatobiliary Pancreat Sci. Volume: 23 Issue: 11 Pages: 721-734
  • DOI: 10.1002/jhbp.405
  • Peer Reviewed
• [Journal Article] Validation of the board certification system for expert surgeons (hepato-biliary-pancreatic field) using the data of the national clinical database of Japan. Part 2: Pancreatodudenectomy (2016)
  • Author(s): Miura F, Yamamoto M, Gotoh, M, Konno H, Fujimoto J, Yanaga K, Kokudo N, Yamaue H, Wakabayashi G, Unno M, Miyata H, Miyazaki M
  • Journal Title: J Hepatobiliary Pancreat Sci. Volume: 印刷中 Issue: 6 Pages: 353-363
  • DOI: 10.1002/jhbp.348
  • Peer Reviewed / Open Access
• [Journal Article] Validation of the board certification system for expert surgeons (hepato-biliary-pancreatic field) using the data of the national clinical database for Japan. Part 1: Hepatectomy of more than 1 segment (2016)
  • Author(s): Miura F, Yamamoto M, Gotoh, M, Konno H, Fujimoto J, Yanaga K, Kokudo N, Yamaue H, Wakabayashi G, Unno M, Miyata H, Miyazaki M
  • Journal Title: J Hepatobiliary Pancreat Sci. Volume: 印刷中 Issue: 6 Pages: 313-323
  • DOI: 10.1002/jhbp.344
  • Peer Reviewed / Open Access
• [Presentation] Collaborative projects of NCD and NSQIP for quality improvement gastroenterological surgery. (2019)
  • Author(s): Kofunato H, Marubashi S, Miyata A, Ko C, Kakeji Y, Seto Y, Gotoh M
  • Organizer: 第119会日本外科学会総会
• [Presentation] 消化器外科におけるNCDを活用した研究課題の成果と今後の展開 (2017)
  • Author(s): 掛地吉弘, 後藤満一, 今野弘之, 宮田裕章, 瀬戸泰之
  • Organizer: 第72 回日本消化器外科学会総会
  • Invited
• [Presentation] 消化器外科関連分野のNCD の現状と展望 (2017)
  • Author(s): 宮田裕章, 掛地吉弘, 今野弘之, 後藤満一, 岩中督, 瀬戸泰之
  • Organizer: 第72 回日本消化器外科学会総会
  • Invited
• [Presentation] NCDを基盤とした消化器外科領域の前向き研究への課題 (2016)
  • Author(s): 後藤満一、掛地吉弘、宮田裕章、瀬戸泰之
  • Organizer: 第116回日本外科学会定期学術集会
  • Place of Presentation: 大阪国際会議場（大阪府大阪市）
  • Year and Date: 2016-04-14
• [Funded Workshop] 米国、ACS-NSQIP (American College of Surgery, National Surgical Quality Improvement Program) (2020)