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

• Published in: World journal of surgery 2021-06, Vol.45 (6), p.1803-1811
• Main Authors: Murakami, Hitoshi, Yamada, Takanobu, Taguri, Masataka, Hasegawa, Shinichi, Yamanaka, Takeharu, Rino, Yasushi, Mushiake, Hiroyuki, Oshima, Takashi, Matsukawa, Hiroshi, Tani, Kazuyuki, Suzuki, Yoshihiro, Ozawa, Yukihiro, Tanabe, Hiroyasu, Osaragi, Tomohiko, Sato, Tsutomu, Tamagawa, Hiroshi, Yukawa, Norio, Yoshikawa, Takaki, Imada, Toshio, Masuda, Munetaka, Yamamoto, Yuji
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adenocarcinoma; Cancer; Cardiac Surgery; Clinical trials; Gastrectomy; Gastric cancer; General Surgery; Median (statistics); Medicine; Medicine & Public Health; Metastases; Morbidity; Mortality; Omentum; Original Scientific Report; Patients; Peritoneum; Preservation; Surgery; Surgical outcomes; Thoracic Surgery; Vascular Surgery
• ISSN: 0364-2313; 1432-2323
• DOI: 10.1007/s00268-021-05988-7

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