Published in:
01-06-2021 | Splenectomy | Original Scientific Report
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
Authors:
Hitoshi Murakami, Takanobu Yamada, Masataka Taguri, Shinichi Hasegawa, Takeharu Yamanaka, Yasushi Rino, Hiroyuki Mushiake, Takashi Oshima, Hiroshi Matsukawa, Kazuyuki Tani, Yoshihiro Suzuki, Yukihiro Ozawa, Hiroyasu Tanabe, Tomohiko Osaragi, Tsutomu Sato, Hiroshi Tamagawa, Norio Yukawa, Takaki Yoshikawa, Toshio Imada, Munetaka Masuda, Yuji Yamamoto
Published in:
World Journal of Surgery
|
Issue 6/2021
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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.