Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401

Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
Hitoshi KataiStomach Cancer Study Group of Japan Clinical Oncology Group

Abstract

Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer is safe and feasible. In contrast, no prospective study evaluating the safety and efficacy of laparoscopy-assisted total gastrectomy (LATG) or laparoscopy-assisted proximal gastrectomy (LAPG) has been completed. We conducted a single-arm confirmatory trial to evaluate the safety of LATG/LAPG for clinical stage I (T1N0/T1N1/T2N0) proximal gastric cancer. The extent of lymphadenectomy was selected based on the Japanese Gastric Cancer Treatment Guidelines. The mini-laparotomy incision was required to be ≤ 6 cm. The primary endpoint was the proportion of grade 2-4 (CTCAE ver. 4.0) esophagojejunal anastomotic leakage. The planned sample size was 245 considering a threshold of 8% and one-sided alpha of 2.5%. Between April 2015 and February 2017, 244 eligible patients were enrolled. LATG/LAPG was performed in 195/49. The proportion of conversions was 1.7%. Clinical T1N0/T1N1/T2N0 was 212/9/23. The extents of lymphadenectomy were as follows: D1+: 229; D2: 15. The median operation time was 309 min (IQR 265-353). The median blood loss was 30 ml (IQR 10-86). Grade 2-4 esophagojejunal anastomotic leakage was 2.5% (6/244; 95% CI 0.9-5.3). The overall proportion of in-hospital...Continue Reading

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Citations

Aug 21, 2020·JAMA Oncology·Fenglin LiuUNKNOWN Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group
May 31, 2020·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Kenichi NakamuraIchiro Uyama
Feb 16, 2020·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·UNKNOWN Japanese Gastric Cancer Association
Mar 18, 2020·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Junya AoyamaShigeki Yamaguchi
Aug 2, 2020·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Nicole van der WielenDonald L van der Peet
Oct 3, 2020·Annals of Gastroenterological Surgery·Souya Nunobe, Satoshi Ida
Jan 27, 2021·Der Chirurg; Zeitschrift für alle Gebiete der operativen Medizen·Marie-Christin WeberDaniel Reim
Aug 12, 2020·Surgical Oncology·Bofei LiSimon Law
Dec 16, 2020·Annals of Gastroenterological Surgery·Marie WashioNaoki Hiki
Dec 4, 2020·European Journal of Surgical Oncology : the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology·Xiao-Dong ChenMi Chen
Apr 17, 2021·Annals of Gastroenterological Surgery·Tomoyuki IrinoYuko Kitagawa
May 8, 2021·Surgical Oncology·Chikara KunisakiItaru Endo
Jun 6, 2021·Updates in Surgery·Marcus Fernando Kodama Pertille RamosSergio Carlos Nahas
May 20, 2021·Arquivos Brasileiros De Cirurgia Digestiva : ABCD = Brazilian Archives of Digestive Surgery·Leandro Cardoso BarchiWilson Rodrigues de Freitas Júnior
Jun 8, 2021·Annals of Gastroenterological Surgery·Toshiyuki KosugaEigo Otsuji
Aug 15, 2021·World Journal of Surgery·Ko IkegameMasanori Terashima
May 12, 2021·Surgical Laparoscopy, Endoscopy & Percutaneous Techniques·Shinta TominagaHiroki Yamaue
Oct 13, 2021·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Koichi SudaIchiro Uyama
Oct 31, 2021·Journal of Robotic Surgery·Tsutomu KumamotoHisashi Shinohara
Nov 7, 2021·Langenbeck's Archives of Surgery·Hideaki SuematsuMunetaka Masuda
Jan 25, 2022·Langenbeck's Archives of Surgery·Masahiro NiiharaKeishi Yamashita
Feb 3, 2022·Asian Journal of Endoscopic Surgery·Tomohiro OsakiYasuaki Hirooka

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