Annals of Surgical Oncology

, Volume 23, Issue 9, pp 2928–2935 | Cite as

Effects of an Oral Elemental Nutritional Supplement on Post-gastrectomy Body Weight Loss in Gastric Cancer Patients: A Randomized Controlled Clinical Trial

  • Hiroshi ImamuraEmail author
  • Kazuhiro Nishikawa
  • Kentaro Kishi
  • Kentaro Inoue
  • Jin Matsuyama
  • Yusuke Akamaru
  • Yutaka Kimura
  • Shigeyuki Tamura
  • Ryohei Kawabata
  • Junji Kawada
  • Yoshiyuki Fujiwara
  • Tomono Kawase
  • Junichi Fukui
  • Mari Takagi
  • Atsushi Takeno
  • Toshio Shimokawa
Gastrointestinal Oncology



Post-gastrectomy weight loss is associated with deterioration in quality of life, and influences the long-term prognosis of gastric cancer patients. We conducted a prospective, randomized controlled, open-label study to examine whether an oral elemental diet (Elental®, Ajinomoto Pharmaceuticals, Tokyo, Japan; hereafter referred to as ED) prevents postoperative weight loss in post-gastrectomy patients.


Patients were randomly divided to receive the ED or control diet. The ED group received 300 kcal of ED plus their regular diet for 6–8 weeks after surgery, starting from the day the patient started a soft rice or equivalent diet after surgery, while the control group received the regular diet alone. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical body weight to that at 6–8 weeks after surgery. Secondary endpoints were dietary adherence, nutrition-related blood parameters, and adverse events.


This study included 112 patients in eight hospitals. The mean treatment compliance rate in the ED group was 68.7 ± 30.4 % (median 81.2 %). The %BWL was significantly different between the ED and control groups (4.86 ± 3.72 vs. 6.60 ± 4.90 %, respectively; p = 0.047). In patients who underwent total gastrectomy, the %BWL was significantly different between the two groups (5.03 ± 3.65 vs. 9.13 ± 5.43 %, respectively; p = 0.012). In multivariate analysis, ED treatment, surgery type, and preoperative performance status were independently associated with %BWL. No significant differences were observed in the other clinical variables.


ED supplementation reduced postoperative weight loss in gastric cancer patients undergoing gastrectomy.


Gastric Cancer Patient Total Gastrectomy Body Weight Loss Distal Gastrectomy Postoperative Weight Loss 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors would like to thank all KSES collaborators, investigators, and patients for their participation and contribution to this study; Manabu Suzuki, PhD, and Yoshiki Kurose, employees of the Medical Science Department, Ajinomoto Pharmaceuticals Co., Ltd, for providing technical help in data management and writing assistance; Prof. Setsuko Anami, PhD, Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Doshisha Women’s College of Liberal Arts, Kyotanabe, Kyoto, Japan, for her clinical review of adverse events, and proofing and approving the final version of manuscript; Ajinomoto Pharmaceuticals Co., Ltd for providing meeting room facilities; and Nicholas D. Smith, PhD, of Edanz Group Ltd, for providing editorial assistance.

Author Contributions

Conceived and designed the study: Hiroshi Imamura and Ryohei Kawabata. Participated in data acquisition: Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Kentaro Inoue, Jin Matsuyama, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Junji Kawada, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, and Atsushi Takeno. Statistical analysis and interpretation of data: Hiroshi Imamura. Statistical analysis of data: Toshio Shimokawa. Drafted the article: Hiroshi Imamura. Proofed and approved the final manuscript: Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, Atsushi Takeno, and Toshio Shimokawa. All authors had access to the data and jointly decided to submit the manuscript.


Hiroshi Imamura, Kazuhiro Nishikawa, Kentaro Kishi, Kentaro Inoue, Jin Matsuyama, Yusuke Akamaru, Yutaka Kimura, Shigeyuki Tamura, Ryohei Kawabata, Junji Kawada, Yoshiyuki Fujiwara, Tomono Kawase, Junichi Fukui, Mari Takagi, Atsushi Takeno, and Toshio Shimokawa declare they have no potential conflicts of interest.

Supplementary material

10434_2016_5221_MOESM1_ESM.docx (158 kb)
Supplementary material 1 (DOCX 157 kb)


  1. 1.
    Onodera H, Tokunaga A, Yoshiyuki T, et al. Surgical outcome of 483 patients with early gastric cancer: prognosis, postoperative morbidity and mortality, and gastric remnant cancer. Hepatogastroenterology. 2004;51:82–5.PubMedGoogle Scholar
  2. 2.
    Kong H, Kwon OK, Yu W. Changes of quality of life after gastric cancer surgery. J Gastric Cancer. 2012;12:194–200.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012;13:401–6.CrossRefPubMedGoogle Scholar
  4. 4.
    Fujitani K, Tsujinaka T, Fujita J, et al. Prospective randomized trial of preoperative enteral immunonutrition followed by elective total gastrectomy for gastric cancer. Br J Surg. 2012;99:621–9.CrossRefPubMedGoogle Scholar
  5. 5.
    Li J, Ji Z, Yuan C, et al. Limited efficacy of early enteral nutrition in patients after total gastrectomy. J Invest Surg. 2011;24:103–8.CrossRefPubMedGoogle Scholar
  6. 6.
    Kim HU, Chung JB, Kim CB. The comparison between early enteral nutrition and total parenteral nutrition after total gastrectomy in patients with gastric cancer: the randomized prospective study [in Korean]. Korean J Gastroenterol. 2012;59:407–13.CrossRefPubMedGoogle Scholar
  7. 7.
    Rogers C. Postgastrectomy nutrition. Nutr Clin Pract. 2011;26:126–36.CrossRefPubMedGoogle Scholar
  8. 8.
    Fukui T, Itoh Y, Orihara M, et al. Elental prevented and reduced oral mucositis during chemotherapy in patients esophageal cancer [in Japanese]. Gan To Kagaku Ryoho 2011;38:2597–601.PubMedGoogle Scholar
  9. 9.
    Ogata Y, Takeuchi M, Ishibashi N, et al. Efficacy of Elental on prevention for chemotherapy-induced oral mucositis in colorectal cancer patients [in Japanese]. Gan To Kagaku Ryoho. 2012;39:583–7.PubMedGoogle Scholar
  10. 10.
    Sakuramoto S, Sasako M, Yamaguchi T, et al. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007;357:1810–20.CrossRefPubMedGoogle Scholar
  11. 11.
    Park HS, Jung M, Kim HS, et al. Proper timing of adjuvant chemotherapy affects survival in patients with stage 2 and 3 gastric cancer. Ann Surg Oncol. 2015;22(1):224–31.CrossRefPubMedGoogle Scholar
  12. 12.
    Fein M, Fuchs KH, Thalheimer A, Freys SM, Heimbucher J, Thiede A. Long-term benefits of Roux-en-Y pouch reconstruction after total gastrectomy: a randomized trial. Ann Surg. 2008;247:759–65.CrossRefPubMedGoogle Scholar
  13. 13.
    Liedman B, Andersson H, Bosaeus I, Hugosson I, Lundell L. Changes in body composition after gastrectomy: results of a controlled, prospective clinical trial. World J Surg. 1997;21:416–20.CrossRefPubMedGoogle Scholar
  14. 14.
    Takachi K, Doki Y, Ishikawa O, et al. Postoperative ghrelin levels and delayed recovery from body weight loss after distal or total gastrectomy. J Surg Res. 2006;130:1–7.CrossRefPubMedGoogle Scholar
  15. 15.
    Kiyama T, Mizutani T, Okuda T, et al. Postoperative changes in body composition after gastrectomy. J Gastrointest Surg. 2005;9:313–9.CrossRefPubMedGoogle Scholar
  16. 16.
    Abdiev S, Kodera Y, Fujiwara M, et al. Nutritional recovery after open and laparoscopic gastrectomies. Gastric Cancer. 2011;14:144–9.CrossRefPubMedGoogle Scholar
  17. 17.
    Hirao M, Takiguchi S, Imamura H, et al. Comparison of Billroth I and Roux-en-Y reconstruction after distal gastrectomy for gastric cancer: one-year postoperative effects assessed by a multi-institutional RCT. Ann Surg Oncol. 2013;20:1591–7.CrossRefPubMedGoogle Scholar
  18. 18.
    Kurokawa Y, Sasako M, Sano T, et al. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011;98:239–45.CrossRefPubMedGoogle Scholar
  19. 19.
    Adachi Y, Shiraishi N, Shiromizu A, Bandoh T, Aramaki M, Kitano S. Laparoscopy-assisted Billroth I gastrectomy compared with conventional open gastrectomy. Arch Surg. 2000;135:806–10.CrossRefPubMedGoogle Scholar
  20. 20.
    Bozzetti F, SCRINIO Working Group. Screening the nutritional status in oncology: a preliminary report on 1,000 outpatients. Support Care Cancer. 2009;17:279–84.CrossRefGoogle Scholar
  21. 21.
    Braga M, Gianotti L, Gentilini O, Parisi V, Salis C, Di Carlo V. Early postoperative enteral nutrition improves gut oxygenation and reduces costs compared with total parenteral nutrition. Crit Care Med. 2001;29:242–8.CrossRefPubMedGoogle Scholar
  22. 22.
    Aoyama T, Yoshikawa T, Shirai J, et al. Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer. Ann Surg Oncol. 2013;20:2000–6.CrossRefPubMedGoogle Scholar
  23. 23.
    Horiuchi A, Nakayama Y, Sakai R, Suzuki M, Kajiyama M, Tanaka N. Elemental diets may reduce the risk of aspiration pneumonia in bedridden gastrostomy-fed patients. Am J Gastroenterol. 2013;108:804–10.CrossRefPubMedPubMedCentralGoogle Scholar
  24. 24.
    Adachi S, Takiguchi S, Okada K, et al. Effects of ghrelin administration after total gastrectomy: a prospective, randomized, placebo-controlled phase II study. Gastroenterology. 2010;138:1312–20.CrossRefPubMedGoogle Scholar
  25. 25.
    Ryan AM, Reynolds JV, Healy L, et al. Enteral nutrition enriched with eicosapentaenoic acid (EPA) preserves lean body mass following esophageal cancer surgery: results of a double-blinded randomized controlled trial. Ann Surg. 2009;249:355–63.CrossRefPubMedGoogle Scholar
  26. 26.
    Yoshikawa T, Hiki N, Taguri M, et al. A phase III trial to evaluate the effect of perioperative nutrition enriched with eicosapentaenoic acid on body weight loss after total gastrectomy for T2-T4a gastric cancer. Jpn J Clin Oncol. 2012;42:459–62.CrossRefPubMedGoogle Scholar
  27. 27.
    Papapietro K, Díaz E, Csendes A, et al. Early enteral nutrition in cancer patients subjected to a total gastrectomy. Rev Med Chil. 2002;130:1125–30.CrossRefPubMedGoogle Scholar

Copyright information

© Society of Surgical Oncology 2016

Authors and Affiliations

  • Hiroshi Imamura
    • 1
    Email author
  • Kazuhiro Nishikawa
    • 2
  • Kentaro Kishi
    • 3
  • Kentaro Inoue
    • 4
  • Jin Matsuyama
    • 5
  • Yusuke Akamaru
    • 6
  • Yutaka Kimura
    • 7
  • Shigeyuki Tamura
    • 8
  • Ryohei Kawabata
    • 9
  • Junji Kawada
    • 10
  • Yoshiyuki Fujiwara
    • 11
  • Tomono Kawase
    • 1
  • Junichi Fukui
    • 4
  • Mari Takagi
    • 11
  • Atsushi Takeno
    • 8
  • Toshio Shimokawa
    • 12
  1. 1.Department of SurgeryToyonaka Municipal HospitalToyonakaJapan
  2. 2.Department of SurgeryOsaka National HospitalOsakaJapan
  3. 3.Department of SurgeryOsaka Police HospitalOsakaJapan
  4. 4.Department of SurgeryKansai Medical UniversityHirakataJapan
  5. 5.Department of SurgeryYao Municipal HospitalOsakaJapan
  6. 6.Department of SurgeryIkeda Municipal HospitalOsakaJapan
  7. 7.Department of SurgerySakai Municipal HospitalOsakaJapan
  8. 8.Department of SurgeryKansai Rosai HospitalHyogoJapan
  9. 9.Department of SurgeryOsaka Rosai HospitalOsakaJapan
  10. 10.Department of SurgeryKaizuka City HospitalOsakaJapan
  11. 11.Department of PharmacyOsaka General Medical CenterOsakaJapan
  12. 12.Clinical Study Support CenterWakayama Medical UniversityWakayamaJapan

Personalised recommendations