A Prospective, Randomized Trial of Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tolerance of Oral Intake
研究概览
简要总结
Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.
详细描述
Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periampullar carcinoma
- •Pancreaticoduodenectomy
- •ERAS protocol implemented
排除标准
- •Preoperative Radiotherapy/chemotherapy
- •Unresectable primary cancer
- •Palliative surgery
- •New York Heart Association class>3
研究组 & 干预措施
1 early oral intake
early oral intake since postoperative day 1.
干预措施: early oral intake (Procedure)
2 jejunostomy tube feeding (JTF)
jejunostomy tube feeding (JTF) was carried out after PD
干预措施: jejunostomy tube feeding (JTF) (Procedure)
结局指标
主要结局
Tolerance of Oral Intake
时间窗: postoperative 1 to 7day
the amount of oral intake is recorded, including clear fluids, soft and solid food.
次要结局
- morbidity rate(postoperative 1day to discharge, up to 8 weeks)
- length of stay(postoperative 1day to discharge,up to 8 weeks)
- Readmission rate(30 days after discharge)
- Hospital costs(postoperative 1day to discharge,up to 8 weeks)
- Albumin(postoperative 30d)
- weight(postoperative 30d)
- height(postoperative 30d)
研究者
Zheng Chen
the director of general surgery;
Xuzhou Medical University