Comparison of Clinical Outcomes and Nutritional Status Between Conventional Oral Intake and Delayed Oral Intake With Jejunostomy Feeding After Esophagectomy: An Open Labeled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Percentage of body weight loss
研究概览
简要总结
Comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer
详细描述
Esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and is associated with a poor prognosis. The 5-year overall survival rate is 40.0 % and the 30-day mortality rate is 1.7 %. Surgical resection is the most effective treatment for localized esophageal cancer; however, esophagectomy is extremely invasive and is associated with high morbidity and mortality rates.
Nutrition is one of the most important factors to consider after esophagectomy in order to reduce surgical mortality. The European Society for Parenteral and Enteral Nutrition guidelines recommend early tube feeding after major gastrointestinal surgery for cancer. Several studies have shown that enteral nutrition is more effective than parenteral nutrition in reducing postoperative complications in postesophagectomy patients. It has been reported that 5 to 7 days are required for anastomosis site healing. Therefore, many centers start oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation, and enteral feeding via jejunostomy are maintained for nutritional support. However, the optimal timing for oral feeding after esophagectomy is still under debate.
In our center, the investigators routinely place jejunostomy tube for sufficient enteral feeding after esophagectomy. Before 2014, the investigators started oral feeding 5 to 7 days after esophagectomy and patients were discharged with soft blended diet. After 2014, the investigators changed our postoperative management protocols: 1) the investigators started only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube. However, no studies have been conducted showing the optimal timing for oral feeding for esophagectomy patients for nutritional support and postoperative care.
The investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy feeding is superior to conventional oral feeding for nutritional support and early clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose
- •Patients who can understand the purpose and protocol of the clinical trial
排除标准
- •BMI < 18kg/m2 or BMI > 25kg/m2
- •Patients who needs colon of jejunum for esophageal reconstruction
- •Patients who needed enteral feeding before esophagectomy
- •Preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure)
- •Severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease)
- •Other patients who are not suitable for clinical trial
结局指标
主要结局
Percentage of body weight loss
时间窗: at postoperative 1st visit (postoperative 4-5 weeks)
Percentage of body weight loss from preoperative body weight
次要结局
- Postoperative Nutritional index(at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months)
- Postoperative daily protein intake(at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months)
- Postoperative complication rate(From date of randomization until the date of discharge after operation, assessed up to 2 months)
- Complication related to jejunostomy feeding(From date of randomization until the date of discharge after operation, assessed up to 2 months)
- Postoperative daily total calorie intake(at postoperative 1st visit (postoperative 4-5 weeks), at postoperative 3-4 months)