Short-Term Outcomes from a Randomized Screening Phase II Non-inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP-G Trial.

Autor: Murakami H; Department of Surgery, Kamishirane Hospital, Yokohama, Japan., Yamada T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi, Yokohama Kanagawa, Japan. takay0218@yahoo.co.jp., Taguri M; Department of Data Science, Yokohama City University, Yokohama, Japan., Hasegawa S; Hasegawa Medical Clinic, Yokohama, Japan., Yamanaka T; Department of Biostatistics, Yokohama City University, Yokohama, Japan., Rino Y; Department of Surgery, Yokohama City University, Yokohama, Japan., Mushiake H; Department of Surgery, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan., Oshima T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi, Yokohama Kanagawa, Japan., Matsukawa H; Department of Surgery, Yokohama Minami Kyosai Hospital, Yokohama, Japan., Tani K; Department of Surgery, Hiratsuka Kyosai Hospital, Hiratsuka, Japan., Suzuki Y; Department of Surgery, Kanagawa Prefectural Ashigarakami Hospital, Matsuda, Japan., Ozawa Y; Department of Surgery, Miura City Hospital, Miura, Japan., Tanabe H; Department of Surgery, International University of Health and Welfare Atami Hospital, Atami, Japan., Osaragi T; Department of Surgery, Japanese Red Cross Hadano Hospital, Hadano, Japan., Sato T; Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan., Tamagawa H; Department of Surgery, Yokohama City University, Yokohama, Japan., Yukawa N; Department of Surgery, Yokohama City University, Yokohama, Japan., Yoshikawa T; Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan. tayoshik@ncc.go.jp., Imada T; Department of Surgery, Chigasaki Chuo Hospital, Chigasaki, Japan., Masuda M; Department of Surgery, Yokohama City University, Yokohama, Japan., Yamamoto Y; Department of Surgery, Fujisawa Shonandai Hospital, Fujisawa, Japan.
Jazyk: angličtina
Zdroj: World journal of surgery [World J Surg] 2021 Jun; Vol. 45 (6), pp. 1803-1811. Date of Electronic Publication: 2021 Feb 10.
DOI: 10.1007/s00268-021-05988-7
Abstrakt: 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.
Databáze: MEDLINE
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