早期胃癌行腹腔镜和开腹全胃切除术RCT研究(CLASS-02)进展
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摘要
胃癌腹腔镜和开腹根治性全胃切除术安全性的多中心、随机、对照临床研究(CLASS-02)是中国腹腔镜胃肠外科研究组(CLASS)成立后的第2个系列研究,目前已基本完成入组和数据核查工作,预计2019年6月将完成数据分析。CLASS-02研究设计及实施过程中对医学伦理学、入组病例基线评估、消化道重建方式、并发症记录、严重不良事件预案、随访、数据管理等方面问题进行了严格的质量控制。CLASS-02研究完成入组将为后续的腹腔镜全胃切除术的有效性Ⅲ期临床研究(CLASS-02.2)奠定基础。CLASS系列研究将助力中国高质量临床研究数据的发布和外科技术创新。
CLASS-02 was the second study since the estab-lishment of Chinese Laparoscopic Gastrointestinal SurgeryStudy Group(CLASS). Till now, the enrollment and data verifi-cation had been nearly completed, and it was expected to fin-ish the data analysis in June 2019. Under strict quality control,each of the process included medical ethics, baseline assess-ment, surgical standardization,evaluation of morbidity, follow-up, and data management was well considered during thestudy. The results of CLASS-02 study will set a solid founda-tion for the subsequent phase III clinical trial on efficacy oflaparoscopic total gastrectomy. We hope that the CLASS seriesstudies will facilitate the release of high-quality clinical re-search data and surgical innovation forgastriccancerin China.
CLASS-02 was the second study since the estab-lishment of Chinese Laparoscopic Gastrointestinal SurgeryStudy Group(CLASS). Till now, the enrollment and data verifi-cation had been nearly completed, and it was expected to fin-ish the data analysis in June 2019. Under strict quality control,each of the process included medical ethics, baseline assess-ment, surgical standardization,evaluation of morbidity, follow-up, and data management was well considered during thestudy. The results of CLASS-02 study will set a solid founda-tion for the subsequent phase III clinical trial on efficacy oflaparoscopic total gastrectomy. We hope that the CLASS seriesstudies will facilitate the release of high-quality clinical re-search data and surgical innovation forgastriccancerin China.
引文
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[16]Information-Committee-of-Korean-Gastric-Cancer-Association.Korean Gastric Cancer Association Nationwide Survey on Gastric Cancer in 2014[J].J Gastric Cancer,2016,16(3):131-140.
[17]Jeong O,Park YK.Clinicopathological features and surgical treatment of gastric cancer in South Korea:the results of 2009nationwide survey on surgically treated gastric cancer patients[J].J Gastric Cancer,2011,11(2):69-77.
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[20]Yanai H,Noguchi T,Mizumachi S,et al.A blind comparison of the effectiveness of endoscopic ultrasonography and endoscopy in staging early gastric cancer[J].Gut,1999,44(3):361-365.
[2]Kim W,Kim HH,Han SU,et al.Decreased morbidity of laparoscopic distal gastrectomy compared with open distal gastrectomy for stage I gastric cancer:short-term outcomes from a Multicenter Randomized Controlled Trial(KLASS-01)[J].Ann Surg,2016,263(1):28-35.
[3]Kim HH,Han SU,Kim MC,et al.Effect of laparoscopic distal gastrectomy vs open distal gastrectomy on long-term survival among patients with stage I gastric cancer:The KLASS-01 Randomized Clinical Trial[J].JAMA Oncol,2019[Epub ahead of print].
[4]Katai H,Sasako M,Fukuda H,et al.Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer:a multicenter phase II trial(JCOG 0703)[J].Gastric Cancer,2010,13(4):238-244.
[5]Hiki N,Katai H,Mizusawa J,et al.Long-term outcomes of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer:a multicenter phase II trial(JCOG0703)[J].Gastric Cancer,2018,21(1):155-161.
[6]Katai H,Mizusawa J,Katayama H,et al.Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer:Japan Clinical Oncology Group Study JCOG0912[J].Gastric Cancer,2017,20(4):699-708.
[7]Park YK,Yoon HM,Kim YW,et al.Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer:Results From a Randomized Phase II Multicenter Clinical Trial(COACT 1001)[J].Ann Surg,2018,267(4):638-645.
[8]Hur H,Lee HY,Lee HJ,et al.Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer:the protocol of the KLASS-02 multicenter randomized controlled clinical trial[J].BMC Cancer,2015,15:355.
[9]Hu Y,Huang C,Sun Y,et al.Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer:A Randomized Controlled Trial[J].J Clin Oncol,2016,34(12):1350-1357.
[10]Inaki N,Etoh T,Ohyama T,et al.A Multi-institutional,Prospective,Phase II Feasibility Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally Advanced Gastric Cancer(JLSSG0901)[J].World J Surg,2015,39(11):2734-2741.
[11]Dubecz A,Solymosi N,Stadlhuber RJ,et al.Does the incidence of adenocarcinoma of the esophagus and gastric cardia continue to rise in the twenty-first century?-a SEER Database Analysis[J].J Gastrointest Surg,2013.[Epub ahead of print].
[12]Ahn HS,Lee HJ,Yoo MW,et al.Changes in clinicopathological features and survival after gastrectomy for gastric cancer over a 20-year period[J].Br J Surg,2011,98(2):255-260.
[13]Jeong GA,Cho GS,Kim HH,et al.Laparoscopy-assisted total gastrectomy for gastric cancer:a multicenter retrospective analysis[J].Surgery,2009,146(3):469-474.
[14]Nashimoto A,Akazawa K,Isobe Y,et al.Gastric cancer treated in 2002 in Japan:2009 annual report of the JGCA nationwide registry[J].Gastric Cancer,2013,16(1):1-27.
[15]Ren W,Yu J,Zhang ZM,et al.Missed diagnosis of early gastric cancer or high-grade intraepithelial neoplasia[J].World JGastroenterol,2013,19(13):2092-2096.
[16]Information-Committee-of-Korean-Gastric-Cancer-Association.Korean Gastric Cancer Association Nationwide Survey on Gastric Cancer in 2014[J].J Gastric Cancer,2016,16(3):131-140.
[17]Jeong O,Park YK.Clinicopathological features and surgical treatment of gastric cancer in South Korea:the results of 2009nationwide survey on surgically treated gastric cancer patients[J].J Gastric Cancer,2011,11(2):69-77.
[18]Choi J,Kim SG,Im JP,et al.Comparison of endoscopic ultrasonography and conventional endoscopy for prediction of depth of tumor invasion in early gastric cancer[J].Endoscopy,2010,42(9):705-713.
[19]Tsujii Y,Kato M,Inoue T,et al.Integrated diagnostic strategy for the invasion depth of early gastric cancer by conventional endoscopy and EUS[J].Gastrointest Endosc,2015,82(3):452-459.
[20]Yanai H,Noguchi T,Mizumachi S,et al.A blind comparison of the effectiveness of endoscopic ultrasonography and endoscopy in staging early gastric cancer[J].Gut,1999,44(3):361-365.