Surgery
Volume 145, Issue 6 , Pages 598-602 , June 2009

Challenges in performing surgical randomized controlled trials in Japan

  • Mitsuru Sasako, MD, PhD

      Affiliations

    • Hyogo College of Medicine, Hyogo, Japan
    • Corresponding Author InformationReprint requests: Mitsuru Sasako, MD, PhD, Division of Upper Gastrointestinal Surgery, Hyogo College of Medicine, 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan.
    • ,
  • Yukinori Kurokawa, MD, PhD

      Affiliations

    • Osaka National Hospital, Osaka, Japan

,Accepted 13 March 2009.

References 

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  2. Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, et al. Extended lymph node dissection for gastric cancer. N Engl J Med. 1999;340:908–914
  3. Sasako M. Clinical trials of surgical treatment of malignant diseases. Int J Oncol. 2005;10:165–170
  4. Bunt AM, Hermans J, Boon MC, van de Velde CJ, Sasako M, Fleuren GJ, et al. Evaluation of the extent of lymphadenectomy in a randomized trial of Western- versus Japanese-type surgery in gastric cancer. J Clin Oncol. 1994;12:417–422
  5. Brennan MF. Lymph-node dissection for gastric cancer. N Engl J Med. 1999;340:956–957
  6. Hundahl SA. Surgical quality control in gastric cancer trials. Surg Oncol Clin N Am. 2002;11:445–458
  7. Parikh D, Johnson M, Chagla L, Lowe D, McCulloch P. D2 gastrectomy: lessons from a prospective audit of the learning curve. Br J Surg. 1996;83:1595–1599
  8. Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, et al. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy–Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004;22:2767–2773
  9. Van Lanschot JJ, Hulscher JB, Buskens CJ, Tilanus HW, ten Kate FJ, Obertop H. Hospital volume and hospital mortality for esophagectomy. Cancer. 2001;91:1574–1578
  10. Gordon TA, Bowman HM, Tielsch JM, Bass EB, Burley GP, Cameron JL. Statewide regionalization of pancreaticoduodenectomy and its effect on in-hospital mortality. Ann Surg. 1998;228:71–78
  11. Sasako M. Risk factors for surgical treatment in the Dutch gastric cancer trial. Br J Surg. 1997;84:1567–1571
  12. Guller U. Caveats in the interpretation of the surgical literature. Br J Surg. 2008;95:541–546
  13. Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmerman GN, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001;345:725–730
  14. Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJH. Quality control of lumph node dissection in the Dutch randomized trial of D1 and D2 lymph node dissection for gastric cancer. Gastric Cancer. 1998;1:152–159
  15. Bunt AMG, Hermans J, Boon MC, van de Velde CJH, Sasako M, Hoefsloot FAM, et al. Lymph node retrieval in a ramdomized trial on Western-type versus Japanese-type surgery in gastric cancer. J Clin Oncol. 1996;14:2289–2294
  16. Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Surgical treatment of advanced gastric cancer: Japanese perspective. Dig Surg. 2007;24:101–107
  17. Hulscher JBF, van Sandick JW, de Boer AGEM, Wijnhoven BPL, Tijssen JGP, Fockens P, et al. Extended transthoracic resection compared with limited transhiatal resection for for adenocarcinoma of the esophagus. N Engl J Med. 2002;347:1662–1669
  18. 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;359:453–462
  19. 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;7:644–651
  20. Sano T, Yamamoto S, Sasako M. Randomized controlled trial to evaluate splenectomy for proximal gastric carcinoma: Japan Clinical Oncology Group Study JCOG0110-MF. Jpn J Clin Oncol. 2002;32:363–364
  21. Kurokawa Y, Katai H, Fukuda H, Sasako M. Phase II study of laparoscopy-assisted distal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group Study JCOG 0703. Jpn J Clin Oncol. 2008;38:501–503

PII: S0039-6060(09)00141-X

doi: 10.1016/j.surg.2009.03.008

Surgery
Volume 145, Issue 6 , Pages 598-602 , June 2009

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