Phase II Protocol on the Safety and Nutritional Status of Postoperative Enteral Nutrition Using HINEX® E-gel LC in Patients with Esophageal Cancer Undergoing Minimally Invasive Esophagectomy.

backgroundEnteral nutrition therapy in the early postoperative period is essential for patients with esophageal cancer following esophagectomy. HINEX® E-gel LC is an oligomeric formula with various nutrients, including dietary fiber pectin. It is expected to reduce symptoms, such as diarrhea, resulting in improved adherence and a decreased rate of weight loss. However, no reports have examined the adherence to or efficacy of nutritional support therapy using HINEX® E-gel LC after esophagectomy.

methodsThis is a single-institution, single-arm phase II trial. We plan to recruit 32 patients with esophageal cancer who have undergone minimally invasive esophagectomy (MIE) and place an enteral feeding tube. Enteral feeding is to be initiated on the second postoperative day, and the patient is to remain on enteral feeding at 300 kcal/day after discharge. The primary endpoint is adherence to enteral nutrition with HINEX® E-gel LC for up to 2 months postoperatively. The secondary endpoint is the association between the adherence to HINEX® E-gel LC and each nutritional parameter, such as hematological examination, body weight, and psoas muscle. DISCUSSION: Although enteral nutrition is usually initiated in the early postoperative period after esophagectomy, the use of fat-containing digestive agents in the early postoperative period is a novel approach. To the best of our knowledge, this study is the first to evaluate the safety and nutritional status of early postoperative enteral nutrition using fat-containing digestive agents after MIE. Efficient nutritional support therapy using fat-containing digestive agents is expected to be especially useful after esophagectomy when oral intake is significantly decreased.