Hitoshi Murakami1, Takanobu Yamada2, Masataka Taguri3, Shinichi Hasegawa4, Takeharu Yamanaka5, Yasushi Rino6, Hiroyuki Mushiake7, Takashi Oshima8, Hiroshi Matsukawa9, Kazuyuki Tani10, Yoshihiro Suzuki11, Yukihiro Ozawa12, Hiroyasu Tanabe13, Tomohiko Osaragi14, Tsutomu Sato15, Hiroshi Tamagawa6, Norio Yukawa6, Takaki Yoshikawa16, Toshio Imada17, Munetaka Masuda6, Yuji Yamamoto18. 1. Department of Surgery, Kamishirane Hospital, Yokohama, Japan. 2. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi, Yokohama Kanagawa, Japan. takay0218@yahoo.co.jp. 3. Department of Data Science, Yokohama City University, Yokohama, Japan. 4. Hasegawa Medical Clinic, Yokohama, Japan. 5. Department of Biostatistics, Yokohama City University, Yokohama, Japan. 6. Department of Surgery, Yokohama City University, Yokohama, Japan. 7. Department of Surgery, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan. 8. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi, Yokohama Kanagawa, Japan. 9. Department of Surgery, Yokohama Minami Kyosai Hospital, Yokohama, Japan. 10. Department of Surgery, Hiratsuka Kyosai Hospital, Hiratsuka, Japan. 11. Department of Surgery, Kanagawa Prefectural Ashigarakami Hospital, Matsuda, Japan. 12. Department of Surgery, Miura City Hospital, Miura, Japan. 13. Department of Surgery, International University of Health and Welfare Atami Hospital, Atami, Japan. 14. Department of Surgery, Japanese Red Cross Hadano Hospital, Hadano, Japan. 15. Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan. 16. Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan. tayoshik@ncc.go.jp. 17. Department of Surgery, Chigasaki Chuo Hospital, Chigasaki, Japan. 18. Department of Surgery, Fujisawa Shonandai Hospital, Fujisawa, Japan.
Abstract
BACKGROUND: Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS: The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. RESULTS: A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. CONCLUSIONS:Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.
RCT Entities:
BACKGROUND: Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS: The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. RESULTS: A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. CONCLUSIONS: Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.
Authors: M Ri; S Nunobe; M Honda; E Akimoto; T Kinoshita; S Hori; M Aizawa; H Yabusaki; Y Isobe; H Kawakubo; T Abe Journal: Br J Surg Date: 2020-05-20 Impact factor: 6.939
Authors: A Hagiwara; T Takahashi; K Sawai; H Taniguchi; M Shimotsuma; S Okano; C Sakakura; H Tsujimoto; K Osaki; S Sasaki Journal: Cancer Res Date: 1993-02-01 Impact factor: 12.701
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Authors: Cas de Jongh; Lianne Triemstra; Arjen van der Veen; Lodewijk A A Brosens; Misha D P Luyer; Jan H M B Stoot; Jelle P Ruurda; Richard van Hillegersberg Journal: Gastric Cancer Date: 2022-09-14 Impact factor: 7.701