Skip to main content
SpringerLink
Log in

Impact of treatment guidelines and pivotal clinical trial results on a surgeon’s decision regarding treatment for gastric cancer: a retrospective cohort study using the National Clinical Database

  • Original Article
  • Published:
Surgery Today Aims and scope Submit manuscript

Abstract

Purposes

The present study evaluated the impact of clinical guidelines for gastric cancer surgery on surgeons' choice of procedure in real-world practice. We focused on the 2014 guideline revision recommending laparoscopic surgery and the evidence concerning splenectomy for prophylactic lymphadenectomy reported in 2015 using the National Clinical Database, which is the most comprehensive database in Japan.

Methods

We investigated the monthly percentages of laparoscopic distal gastrectomies performed for stage I gastric cancer (LDG%) and splenectomies performed during total gastrectomy for advanced cancer (TGS%) between 2014 and 2017. We evaluated the descriptive statistics of the time-series changes in the LDG%, TGS%, and annual trends of outcomes.

Results

In total, 124,787 patients were enrolled. The mean LDG% and TGS% were 69.8% and 9.2%, respectively. The LDG% and TGS% were 66.4% and 16.7%, respectively, in January 2014 and 73.1% and 5.9%, respectively, in December 2017. LDG% consistently increased, and TGS% showed a consistent downward trend throughout the observation period. There was no significant change in this trend after the publication of the guideline recommendations or clinical trial results.

Conclusion

No significant changes in surgical procedures were observed after publication of the guidelines or results of clinical trials.

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
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Felgner S, Ex P, Henschke C. Physicians’ decision making on adoption of new technologies and role of coverage with evidence development: a qualitative study. Value Health. 2018;21(9):1069–76.

    Article  PubMed  Google Scholar 

  2. Wilson CB. Adoption of new surgical technology. BMJ. 2006;332(7533):112–4.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Gabbay J, Walley T. Introducing new health interventions. BMJ. 2006;332(7533):64–5.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Japanese Gastric Cancer A. Japanese classification of gastric carcinoma: 3rd English edition. Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 2011;14(2):101-12.

  5. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric cancer : official journal of the international gastric cancer association and the japanese gastric cancer association. 2017;20(1):1–19.

  6. Katai H, Mizusawa J, Katayama H, Morita S, Yamada T, Bando E, et al. Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial. Lancet Gastroenterol hepatol. 2020;5(2):142–51.

    Article  PubMed  Google Scholar 

  7. Honda M, Yasunaga H, Michihata N, Miyakawa T, Kumazawa R, Matsui H, et al. Impact of guideline recommendation for novel surgical procedures on surgeons’ decisions: a time series analysis of gastric cancer surgeries from a nationwide cohort study. Int J Surg (London, England). 2023;109(3):316–22.

    Google Scholar 

  8. Kurokawa Y, Doki Y, Mizusawa J, Terashima M, Katai H, Yoshikawa T, et al. Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial. Lancet Gastroenterol Hepatol. 2018;3(7):460–8.

    Article  PubMed  Google Scholar 

  9. Sasako M, Sano T, Yamamoto S, Sairenji M, Arai K, Kinoshita T, et al. Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial. Lancet Oncol. 2006;7(8):644–51.

    Article  PubMed  Google Scholar 

  10. Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, et al. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008;359(5):453–62.

    Article  CAS  PubMed  Google Scholar 

  11. Sano T, Sasako M, Mizusawa J, Yamamoto S, Katai H, Yoshikawa T, et al. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma. Ann Surg. 2017;265(2):277–83.

    Article  PubMed  Google Scholar 

  12. Gotoh M, Miyata H, Hashimoto H, Wakabayashi G, Konno H, Miyakawa S, et al. National Clinical Database feedback implementation for quality improvement of cancer treatment in Japan: from good to great through transparency. Surg Today. 2016;46(1):38–47.

    Article  PubMed  Google Scholar 

  13. Japan Society of Endoscopic Surgery. 2014 Clinical Guideline for qualified surgeons 2nd edition (Japanese).

  14. Sano T, Sasako M, Mizusawa J, Katayama H, Katai H, Yoshikawa T, et al. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma (JCOG0110): final survival analysis. J Clin Oncol. 2015. https://doi.org/10.1200/jco.2015.33.3_suppl.103.

    Article  Google Scholar 

  15. Kurita N, Miyata H, Gotoh M, Shimada M, Imura S, Kimura W, et al. Risk model for distal gastrectomy when treating gastric cancer on the basis of data from 33,917 Japanese patients collected using a nationwide web-based data entry system. Ann Surg. 2015;262(2):295–303.

    Article  PubMed  Google Scholar 

  16. Hasegawa H, Takahashi A, Kanaji S, Kakeji Y, Marubashi S, Konno H, et al. Validation of data quality in a nationwide gastroenterological surgical database: the National Clinical Database site-visit and remote audits, 2016–2018. Ann Gastroenterol Surg. 2021;5(3):296–303.

    Article  PubMed  Google Scholar 

  17. Sakuramoto S, Yamashita K, Kikuchi S, Futawatari N, Katada N, Watanabe M, et al. Laparoscopy versus open distal gastrectomy by expert surgeons for early gastric cancer in Japanese patients: short-term clinical outcomes of a randomized clinical trial. Surg Endosc. 2013;27(5):1695–705.

    Article  PubMed  Google Scholar 

  18. Kim YW, Yoon HM, Yun YH, Nam BH, Eom BW, Baik YH, et al. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc. 2013;27(11):4267–76.

    Article  PubMed  Google Scholar 

  19. Vinuela EF, Gonen M, Brennan MF, Coit DG, Strong VE. Laparoscopic versus open distal gastrectomy for gastric cancer: a meta-analysis of randomized controlled trials and high-quality nonrandomized studies. Ann Surg. 2012;255(3):446–56.

    Article  PubMed  Google Scholar 

  20. Katai H, Sasako M, Fukuda H, Nakamura K, Hiki N, Saka M, et al. Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703). Gastric Cancer. 2010;13(4):238–44.

    Article  PubMed  Google Scholar 

  21. Kim HH, Han SU, Kim MC, Kim W, Lee HJ, Ryu SW, et al. Effect of laparoscopic distal gastrectomy vs open distal gastrectomy on long-term survival among patients with stage I gastric cancer: the KLASS-01 randomized clinical trial. JAMA Oncol. 2019;5(4):506–13.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, et al. Effect of laparoscopic vs open distal gastrectomy on 3 year disease-free survival in patients with locally advanced gastric cancer: the CLASS-01 randomized clinical trial. JAMA. 2019;321(20):1983–92.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Wang C, Nishiyama T, Kikuchi S, Inoue M, Sawada N, Tsugane S, et al. Changing trends in the prevalence of H. pylori infection in Japan (1908–2003): a systematic review and meta-regression analysis of 170,752 individuals. Sci Rep. 2017;7(1):15491.

    Article  ADS  PubMed  PubMed Central  Google Scholar 

  24. Watanabe M, Ito H, Hosono S, Oze I, Ashida C, Tajima K, et al. Declining trends in prevalence of Helicobacter pylori infection by birth-year in a Japanese population. Cancer Sci. 2015;106(12):1738–43.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002;27(4):299–309.

    Article  CAS  PubMed  Google Scholar 

  26. Hategeka C, Ruton H, Karamouzian M, Lynd LD, Law MR. Use of interrupted time series methods in the evaluation of health system quality improvement interventions: a methodological systematic review. BMJ Glob Health. 2020. https://doi.org/10.1136/bmjgh-2020-003567.

    Article  PubMed  PubMed Central  Google Scholar 

  27. Weatherburn CJ, Guthrie B, Dreischulte T, Morales DR. Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: systematic review, time series analysis and meta-analysis. Br J Clin Pharmacol. 2020;86(4):698–710.

    Article  PubMed  Google Scholar 

  28. Sloan FA, Valvona J, Perrin JM, Adamache KW. Diffusion of surgical technology. Explor Study J Health Econ. 1986;5(1):31–61.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

We would like to express our gratitude to all surgeons and medical staff for their efforts with data entry.

Funding

None.

Author information

Author notes

  1. Souya Nunobe and Hideki Endo contributed equally to this work.

Authors and Affiliations

  1. Department of Gastroenterological Surgery, Cancer Institute Ariake Hospital, 8-31, Ariake, 3-Chome, Koto-ku, Tokyo, 135-8550, Japan

    Souya Nunobe & Masayuki Watanabe

  2. Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Hideki Endo & Hiroyuki Yamamoto

  3. Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, Fukushima, Japan

    Michitaka Honda

  4. Project Management Subcommittee, The Japanese Society of Gastroenterological Surgery, Tokyo, Japan

    Shingo Kanaji

  5. Database Committee, The Japanese Society of Gastroenterological Surgery, Tokyo, Japan

    Yoshihiro Kakeji

  6. Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Yasuhiro Kodera

  7. The Japanese Society of Gastroenterological Surgery, Tokyo, Japan

    Yuko Kitagawa

Authors
  1. Souya Nunobe
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hideki Endo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michitaka Honda
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Masayuki Watanabe
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hiroyuki Yamamoto
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Shingo Kanaji
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Yoshihiro Kakeji
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Yasuhiro Kodera
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Yuko Kitagawa
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Souya Nunobe.

Ethics declarations

Conflict of interest

Hideki Endo and Hiroyuki Yamamoto are affiliated with the Department of Healthcare Quality Assessment at the University of Tokyo. The department is a social collaboration department supported by the National Clinical Database, Johnson and Johnson K.K., and the Nipro Corporation. Author Yuko Kitagawa is the Editor of the Chief of Annals of Gastroenterological Surgery. Yoshihiro Kakeji and Yasuhiro Kodera are editorial board members of Annals of Gastroenterological Surgery. All other authors have no conflicts to disclose.

Ethical approval

The study was approved by the Institutional Review Board of the Cancer Institute Hospital (SRB No. 0910), and all study procedures were conducted in accordance with the ethical standards of the respective committees on human experimentation (institutional and national) and the 1964 Declaration of Helsinki and its later versions.

Additional information

Publisher's Note

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

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Nunobe, S., Endo, H., Honda, M. et al. Impact of treatment guidelines and pivotal clinical trial results on a surgeon’s decision regarding treatment for gastric cancer: a retrospective cohort study using the National Clinical Database. Surg Today (2024). https://doi.org/10.1007/s00595-024-02814-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s00595-024-02814-0

Keywords

Search

Navigation