Abstract
Purpose : The purpose of this study was to compare the efficacy and safety of the new enteral nutrition formula ENG-J with a standard enteral nutrition formula Racol®liquid (control) in postoperative patients who underwent esophagectomy or total gastrectomy. Subjects and Methods : This is a multi-center prospective randomized open-label parallel study. Esophageal or gastric cancer patients (N=117) who underwent esophagectomy or total gastrectomy were recruited. Patients were randomly assigned to receive either ENG-J or control via feeding tube starting on postoperative day 3 and administration was continued for 10 days. Efficacy and safety were assessed through measurement of nutritional status and monitoring of adverse events. Result : Fifty-nine patients received ENG-J and 58 patients received control. Intent-To-Treat analysis was done on 59 patients in ENG-J group and 57 patients in control group. There was no difference in nutrition status assessed by RTP (rapid turnover protein), serum total protein, serum albumin,and NI (nutrition index) between ENG-J and control groups. Incidence of adverse events was similar between the two groups. Gastrointestinal disorder was the most frequent type of adverse events in the both groups. Conclusion : ENG-J is an efficacious and safe enteral nutrition formula suitable for postoperative patients.
