A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer

전체 글

(1)pISSN : 2093-582X, eISSN : 2093-5641 J Gastric Cancer 2016;16(2):93-97  http://dx.doi.org/10.5230/jgc.2016.16.2.93. Original Article. Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401 Kozo Kataoka, Hitoshi Katai1, Junki Mizusawa, Hiroshi Katayama, Kenichi Nakamura, Shinji Morita1, Takaki Yoshikawa2, Seiji Ito3, Takahiro Kinoshita4, Takeo Fukagawa1, and Mitsuru Sasako5; Stomach Cancer Study Group/Japan Clinical Oncology Group JCOG Data Center/Operations Office, National Cancer Center, 1Gastric Surgery Division, National Cancer Center Hospital, Tokyo, 2Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, 3 Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, 4Gastric Surgery Division, National Cancer Center Hospital East, Chiba, 5Department of Surgery, Hyogo College of Medicine, Hyogo, Japan. Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155. Key Words: Laparoscopy; Gastrectomy; Nonrandomized clinical trial. DPWFSZPGCPXFMGVODUJPO MFTTQBJO BOEBTIPSUFSIPTQJUBMTUBZ. Introduction. UIBOUIBUGPSPQFOEJTUBMHBTUSFDUPNZ 0%( 5IF4UPNBDI$BO 5IFQSPQPSUJPOPGQBUJFOUTXJUIFBSMZHBTUSJDDBODFSJTNPSF. DFS4UVEZ(SPVQPGUIF+BQBO$MJOJDBM0ODPMPHZ(SPVQ +$0( . UIBOPGUIFUPUBMJODJEFODFTJO+BQBO4JODFUIFGJSTUMBQ. IBTCFFOFOHBHFEJOFTUBCMJTIJOHFWJEFODFGPSMBQBSPTDPQJDHBT. BSPTDPQZBTTJTUFEEJTUBMHBTUSFDUPNZ -"%( GPSFBSMZHBTUSJD. USFDUPNZ8FDPOEVDUFEBNVMUJDFOUFSQIBTF**USJBM +$0( . . DBODFSXBTSFQPSUFEJO UIFOVNCFSPG-"%(TIBTSBQJEMZ. BOEDPOGJSNFEUIFTBGFUZPG-"%(GPSFBSMZHBTUSJDDBODFS8F. JODSFBTFECFDBVTFPGCFUUFSDPTNFUJDPVUDPNFT NPSFSBQJESF. BSFOPXDPOEVDUJOHBSBOEPNJ[FEQIBTF***USJBMUPDPOGJSNUIF OPOJOGFSJPSJUZPG-"%(UP0%(JOUFSNTPGPWFSBMMTVSWJWBM. Correspondence to: Hitoshi Katai Gastric Surgery Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Tel: +81-3-3542-2511, Fax: +81-3-3542-3815 E-mail: [email protected] Received March 29, 2016 Revised May 5, 2016 Accepted May 7, 2016. +$0( 1BUJFOUBDDSVBMIBTBMSFBEZCFFODPNQMFUFE BOE QSJNBSZBOBMZTJTSFTVMUTXJMMCFSFMFBTFEJO$VSSFOU+BQB OFTFHVJEFMJOFTJOEJDBUFUIBUUIFFWJEFODFJTTUJMMUPPXFBLGPS -"%(UPCFDPOTJEFSFEBTUBOEBSEUSFBUNFOUGPSHBTUSJDDBODFS CFDBVTFMPOHUFSNFGGJDBDZIBTOPUCFFOEFNPOTUSBUFEJOBDPO GJSNBUPSZUSJBM5IVT UIFFGGJDBDZSFTVMUTPG+$0(BSFBXBJUFE. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyrights © 2016 by The Korean Gastric Cancer Association. www.jgc-online.org.

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(7) 96 Kataoka K, et al.. UFBDIJOHBTTJTUBOU. 12. Interim analysis and monitoring *OUFSJNBOBMZTJTJTOPUQMBOOFE8IFOUSFBUNFOUSFMBUFE. 9. Intraoperative photographs and video recording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ollow-up. "MMSFHJTUFSFEQBUJFOUTXJMMCFGPMMPXFEVQGPSBUMFBTUZFBST. 13. Participating institutions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tudy design and statistical analysis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cknowledgments. EFSHPHBTUSFDUPNZ5IF,BQMBO.FJFSNFUIPEXJMMCFVTFEGPS BOBMZTJTPGPWFSBMMTVSWJWBMPSSFMBQTFGSFFTVSWJWBM"MMTUBUJTUJDBM BOBMZTFTXJMMCFDPOEVDUFEBUUIF+$0(%BUB$FOUFS. 5IJTTUVEZJTTVQQPSUFECZUIF/BUJPOBM$BODFS$FOUFS3F TFBSDIBOE%FWFMPQNFOU'VOE " BOECZBHSBOUGSPN.

(8) 97 Non-Randomized Confirmatory Trial of LATG and LAPG. UIF"QQMJFE3FTFBSDIGPS*OOPWBUJWF5SFBUNFOUPG$BODFS1SPK. 6. Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu. FDUPGUIF)FBMUIBOE-BCPVS4DJFODFT$PNNJTTJPOGPS3FTFBSDI. Y, Masuda N, et al. Extended Clavien-Dindo classification of. &YQFOTFT ) . surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today 2016;46:668-685.. Conflicts of Interest. 7. Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 2nd English edition. Gastric Cancer. /PQPUFOUJBMDPOGMJDUPGJOUFSFTUSFMFWBOUUPUIJTBSUJDMFXBT SFQPSUFE. 1998;1:10-24. 8. Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4, in Japanese). Tokyo: Kane-. References. hara & Co., Ltd., 2014. 9. Deguchi Y, Fukagawa T, Morita S. Identification of risk factors. 1. Kakizoe T, Yamaguchi N, Mitsuhashi F. Cancer statistics in Japan: foundation for promotion of cancer research 2000. Tokyo, Japan: Foundation for Promotion of Cancer Research, 2001:3639. 2. Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc 1994;4:146148.. for esophagojejunal anastomotic leakage after gastric surgery. World J Surg 2012;36:1617-1622. 10. Sano T, Sasako M, Mizusawa J, Yamamoto S, Katai H, Yoshikawa T, et al. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma. Annals Surg [accepted 2016 May 3]. 11. Ebihara Y, Okushiba S, Kawarada Y, Kitashiro S, Katoh H.. 3. Katai H, Sasako M, Fukuda H, Nakamura K, Hiki N, Saka. Outcome of functional end-to-end esophagojejunostomy in. M, et al; JCOG Gastric Cancer Surgical Study Group. Safety. totally laparoscopic total gastrectomy. Langenbecks Arch Surg. and feasibility of laparoscopy-assisted distal gastrectomy with. 2013;398:475-479.. suprapancreatic nodal dissection for clinical stage I gastric can-. 12. Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ru-. cer: a multicenter phase II trial (JCOG 0703). Gastric Cancer. urda JP, van Hillegersberg R. Laparoscopic total gastrectomy. 2010;13:238-244.. versus open total gastrectomy for cancer: a systematic review. 4. Nakamura K, Katai H, Mizusawa J, Yoshikawa T, Ando M,. and meta-analysis. Surg Endosc 2013;27:1509-1520.. Terashima M, et al. A phase III study of laparoscopy-assisted. 13. Lee MS, Lee JH, Park do J, Lee HJ, Kim HH, Yang HK. Com-. versus open distal gastrectomy with nodal dissection for clini-. parison of short- and long-term outcomes of laparoscopic-. cal stage IA/IB gastric Cancer (JCOG0912). Jpn J Clin Oncol. assisted total gastrectomy and open total gastrectomy in gastric. 2013;43:324-327.. cancer patients. Surg Endosc 2013;27:2598-2605.. 5. National Cancer Institute. Common Terminology Criteria. 14. Wada N, Kurokawa Y, Takiguchi S, Takahashi T, Yamasaki M,. for Adverse Events (CTCAE) version 4.0 [Internet]. Bethesda. Miyata H, et al. Feasibility of laparoscopy-assisted total gas-. (MD): National Cancer Institute; 2010 [cited 2015 Mar 5].. trectomy in patients with clinical stage I gastric cancer. Gastric. Available from: http://evs.nci.nih.gov/ftp1/CTCAE/About.. Cancer 2014;17:137-140.. html..

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