Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Scientific Report
  • Published:
World Journal of Surgery Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Ferlay J, Soerjomataram I, Dikshit R et al (2015) Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359–E586

    Article  CAS  Google Scholar 

  2. Oosterling SJ, van der Bij GJ, Bogels M et al (2006) Insufficient ability of omental milky spots to prevent peritoneal tumor outgrowth supports omentectomy in minimal residual disease. Cancer Immunol Immunother 55:1043–1051

    Article  CAS  Google Scholar 

  3. Hagiwara A, Takahashi T, Sawai K et al (1993) Milky spots as the implantation site for malignant cells in peritoneal dissemination in mice. Cancer Res 53:687–692

    CAS  PubMed  Google Scholar 

  4. Kodera Y, Nakanishi H, Ito S et al (2002) Quantitative detection of disseminated cancer cells in the greater omentum of gastric carcinoma patients with real-time RT-PCR: a comparison with peritoneal lavage cytology. Gastric Cancer 5:69–76

    Article  CAS  Google Scholar 

  5. Hagiwara A, Sawai K, Sakakura C et al (1998) Complete omentectomy and extensive lymphadenectomy with gastrectomy improves the survival of gastric cancer patients with metastases in the adjacent peritoneum. Hepatogastroenterology 45:1922–1929

    CAS  PubMed  Google Scholar 

  6. Etoh T, Sasako M, Ishikawa K et al (2006) Extranodal metastasis is an indicator of poor prognosis in patients with gastric carcinoma. Br J Surg 93:369–373

    Article  CAS  Google Scholar 

  7. Groves EW (1910) On the radical operation for cancer of the pylorus: with especial reference to the advantages of the two-stage operation and to the question of the removal of the associated lymphatics. Br Med J 1:366–370

    Article  CAS  Google Scholar 

  8. Kurokawa Y, Doki Y, Mizusawa J et al (2018) Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol 3:460–468

    Article  Google Scholar 

  9. Ha TK, An JY, Youn HG et al (2008) Omentum-preserving gastrectomy for early gastric cancer. World J Surg 32:1703–1708

    Article  Google Scholar 

  10. Hasegawa S, Kunisaki C, Ono H et al (2013) Omentum-preserving gastrectomy for advanced gastric cancer: a propensity-matched retrospective cohort study. Gastric Cancer 16:383–388

    Article  Google Scholar 

  11. Kim DJ, Lee JH, Kim W (2014) A comparison of total versus partial omentectomy for advanced gastric cancer in laparoscopic gastrectomy. World J Surg Oncol 12:64

    Article  Google Scholar 

  12. Ri M, Nunobe S, Honda M et al (2020) Gastrectomy with or without omentectomy for cT3-4 gastric cancer: a multicentre cohort study. Br J Surg. https://doi.org/10.1002/bjs.11702

    Article  PubMed  Google Scholar 

  13. Hasegawa S, Yamamoto Y, Taguri M et al (2013) A randomized phase II trial of omentum-preserving gastrectomy for advanced gastric cancer. Jpn J Clin Oncol 43:214–216

    Article  Google Scholar 

  14. Japanese Gastric Cancer Association (2017) Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer 20:1–19

    Article  Google Scholar 

  15. Japanese Gastric Cancer Association (2011) Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer 14: 101–112

  16. Sano T, Sasako M, Mizusawa J et al (2017) Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma. Ann Surg 265:277–283

    Article  Google Scholar 

  17. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213

    Article  Google Scholar 

  18. Inoue K, Nakane Y, Michiura T et al (2012) Ultrasonic scalpel for gastric cancer surgery: a prospective randomized study. J Gastrointest Surg 16:1840–1846

    Article  Google Scholar 

  19. Cheng H, Hsiao CW, Clymer JW et al (2015) Gastrectomy and D2 lymphadenectomy for gastric cancer: a meta-analysis comparing the harmonic scalpel to conventional techniques. Int J Surg Oncol 2015:397260

    PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

We thank all of the patients, their families, the investigators, and medical staff members who participated in this study.

Author information

Authors and Affiliations

  1. Department of Surgery, Kamishirane Hospital, Yokohama, Japan

    Hitoshi Murakami

  2. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao Asahi, Yokohama Kanagawa, Japan

    Takanobu Yamada & Takashi Oshima

  3. Department of Data Science, Yokohama City University, Yokohama, Japan

    Masataka Taguri

  4. Hasegawa Medical Clinic, Yokohama, Japan

    Shinichi Hasegawa

  5. Department of Biostatistics, Yokohama City University, Yokohama, Japan

    Takeharu Yamanaka

  6. Department of Surgery, Yokohama City University, Yokohama, Japan

    Yasushi Rino, Hiroshi Tamagawa, Norio Yukawa & Munetaka Masuda

  7. Department of Surgery, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan

    Hiroyuki Mushiake

  8. Department of Surgery, Yokohama Minami Kyosai Hospital, Yokohama, Japan

    Hiroshi Matsukawa

  9. Department of Surgery, Hiratsuka Kyosai Hospital, Hiratsuka, Japan

    Kazuyuki Tani

  10. Department of Surgery, Kanagawa Prefectural Ashigarakami Hospital, Matsuda, Japan

    Yoshihiro Suzuki

  11. Department of Surgery, Miura City Hospital, Miura, Japan

    Yukihiro Ozawa

  12. Department of Surgery, International University of Health and Welfare Atami Hospital, Atami, Japan

    Hiroyasu Tanabe

  13. Department of Surgery, Japanese Red Cross Hadano Hospital, Hadano, Japan

    Tomohiko Osaragi

  14. Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan

    Tsutomu Sato

  15. Department of Gastric Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji Chuo-ku, Tokyo, Japan

    Takaki Yoshikawa

  16. Department of Surgery, Chigasaki Chuo Hospital, Chigasaki, Japan

    Toshio Imada

  17. Department of Surgery, Fujisawa Shonandai Hospital, Fujisawa, Japan

    Yuji Yamamoto

Authors
  1. Hitoshi Murakami
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Takanobu Yamada
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Masataka Taguri
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Shinichi Hasegawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Takeharu Yamanaka
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Yasushi Rino
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Hiroyuki Mushiake
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Takashi Oshima
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Hiroshi Matsukawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Kazuyuki Tani
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Yoshihiro Suzuki
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Yukihiro Ozawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Hiroyasu Tanabe
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Tomohiko Osaragi
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Tsutomu Sato
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Hiroshi Tamagawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Norio Yukawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  18. Takaki Yoshikawa
    View author publications

    You can also search for this author in PubMed Google Scholar

  19. Toshio Imada
    View author publications

    You can also search for this author in PubMed Google Scholar

  20. Munetaka Masuda
    View author publications

    You can also search for this author in PubMed Google Scholar

  21. Yuji Yamamoto
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

SH, TY, and TY conceived of and designed the trial. HM and TY were the principal investigators. MT, HM, TY, and TY were responsible for the data analysis. All authors contributed to the data acquisition and interpretation. HM, TY, and TY draft the article. All authors contributed to the writing of the final manuscript and approved the final version. All authors agree to be accountable for all aspects of the work and to ensure that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding authors

Correspondence to Takanobu Yamada or Takaki Yoshikawa.

Ethics declarations

Conflict of interest

Dr. Yamada reports personal fees from ONO Pharmaceutical and personal fees from Bristol-Myers Squibb, outside the submitted work. Dr. Yamanaka reports grants and personal fees from Takeda, grants and personal fees from Chugai, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Taiho, grants and personal fees from Daiichi-Sankyo, grants from Ono, grants and personal fees from Bayer, grants from Merck Serono, grants from Astellas, grants from Eli Lilly, personal fees from Pfizer, personal fees from Sysmex, personal fees from Huya Biosciences, and personal fees from Gilead Sciences, outside the submitted work. Dr. Rino reports personal fees from Taiho pharmaceutical, personal fees from Abbott, personal fees from Asahi Kasei, personal fees from Daiichi-Sankyo, personal fees from Tsumura & Co, personal fees from Covidien, personal fees from Zeria pharmaceutical, personal fees from EA Pharma, personal fees from Johnson and Johnson, personal fees from Otsuka, other from Lilly, other from Bristol-Myers Squibb, other from Daiichi-Sankyo, other from Johnson and Johnson, other from Otsuka, and other from Taiho pharmaceutical, outside the submitted work. Dr. Oshima reports grants from Taiho pharmaceutical Co., Ltd, grants from Chugai pharmaceutical Co., Ltd, grants from Ono pharmaceutical Co., Ltd, grants from Daiichi-Sankyo pharmaceutical, grants from Nippon Kayaku Co., Ltd, grants from Eli Lilly Japan K. K., personal fees from Nippon Kayaku Co., Ltd, personal fees from Ono pharmaceutical Co., Ltd, personal fees from Bristol-Myers Squibb K. K., personal fees from Taiho pharmaceutical Co., Ltd, personal fees from Chugai pharmaceutical Co., Ltd, and personal fees from Eli Lilly Japan K. K., outside the submitted work. Dr. Yoshikawa reports personal fees from MSD, personal fees from BMS, personal fees from ONO, personal fees from Taiho, personal fees from Chugai, personal fees from Nihon Kayaku, grants and personal fees from Lilly, personal fees from Pfizer, personal fees from TERUMO, personal fees from Johnson and Johnson, and personal fees from Covidien, outside the submitted work; All the remaining authors have no conflicts of interest to declare.

Ethical approval

This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (http://www.umin.ac.jp/ctr/: UMIN000005421) and was approved by the ethical review boards of the participating institutions. All patients provided informed consent before enrollment.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Murakami, H., Yamada, T., Taguri, M. et al. 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. World J Surg 45, 1803–1811 (2021). https://doi.org/10.1007/s00268-021-05988-7

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00268-021-05988-7

Search

Navigation