Long‐term effects of an oral elemental nutritional supplement on post‐gastrectomy body weight loss in gastric cancer patients (KSES002)

AIM: The present study aimed to evaluate the efficacy of short‐term nutritional intervention with an oral elemental diet (ED; Elental; EA Pharma Co., Ltd, Tokyo, Japan) at 300 kcal/day for 6‐8 weeks in the early post‐gastrectomy period on postoperative long‐term body weight loss (BWL). METHODS: We analyzed consecutive patients who were randomly divided to receive the regular diet with or without ED. The control group received regular diet alone post‐gastrectomy, whereas the ED group received 300 kcal ED plus regular diet for 6‐8 weeks. Primary endpoint was percentage (%) BWL (body weight loss; body weight before surgery minus that at postoperative 1 year) by surgical type. Secondary endpoints included changes in nutrition‐related blood parameters. RESULTS: Of the patients in the original trial, 106 were eligible for efficacy analyses. %BWL at postoperative 1 year was significantly lower in the ED group than in the control group among patients who underwent total gastrectomy (TG) (n = 19 and n = 17, respectively; 9.66 ± 5.98% [95% confidence interval, CI: 6.77‐12.54] vs 15.11 ± 6.78% [95% CI: 11.63‐18.60], P = .015), but not in patients who underwent distal gastrectomy (n = 38 and n = 32, respectively; 5.81 ± 7.91% [95% CI: 3.21‐8.41] vs 5.96 ± 6.20% [95% CI: 3.72‐8.19], P = .933). In multivariate analysis, ED was the only factor affecting %BWL at postoperative 1 year among patients who underwent TG. CONCLUSIONS: Daily nutritional intervention (300 kcal/day ED) for 6‐8 weeks reduced %BWL not only at postoperative 6‐8 weeks but also at 1 year in patients who underwent TG.