Nutritional Impact of Prophylactic Feeding Jejunostomy in Major Upper GI Cancer Surgery: A Prospective Cohort Study of 300 Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Absolute change in body weight in kgs from preoperative baseline to 3 months after surgery in patients undergoing major upper gastrointestinal cancer surgery with prophylactic feeding jejunostomy
研究概览
简要总结
Malnutrition is common in patients undergoing major upper gastrointestinal cancer surgery and can negatively affect postoperative recovery and long-term outcomes. Prophylactic feeding jejunostomy (FJ) is frequently placed during surgery to provide early enteral nutrition; however, detailed prospective data on postoperative nutritional recovery in these patients remain limited. This prospective single-center observational cohort study aims to evaluate the nutritional impact of prophylactic feeding jejunostomy in patients undergoing major upper gastrointestinal cancer surgery. A total of 300 consecutive patients undergoing curative surgery such as esophagectomy, gastrectomy, or pancreatoduodenectomy with planned prophylactic FJ placement will be enrolled. The primary outcome is the change in body weight from preoperative baseline to 3 months after surgery. Secondary outcomes include changes in serum albumin levels, the proportion of patients experiencing significant weight loss, postoperative complications, feeding jejunostomy–related complications, and hospital outcomes. Patients will be followed with scheduled weight and laboratory assessments for 3 months after surgery to characterize postoperative nutritional recovery and identify factors associated with poor nutritional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 75 years Histologically confirmed upper gastrointestinal malignancy Patients scheduled for curative-intent major upper GI oncologic surgery such as esophagectomy gastrectomy or pancreatoduodenectomy with planned prophylactic feeding jejunostomy placement ECOG performance status 0 to 2 Ability and willingness to provide written informed consent.
排除标准
- •Patients undergoing palliative surgery only Patients with pre-existing enteral feeding access eg PEG or jejunostomy Known allergy or hypersensitivity to jejunostomy tube materials Expected survival less than 3 months due to advanced disease or severe comorbidities Pregnant patients.
结局指标
主要结局
Absolute change in body weight in kgs from preoperative baseline to 3 months after surgery in patients undergoing major upper gastrointestinal cancer surgery with prophylactic feeding jejunostomy
时间窗: at baseline and at 3 months
次要结局
- Mean change in serum albumin levels from baseline to 3 months(At baseline)
- Incidence & type of FJ related complications graded according to Clavien Dindo classification(Within 3 months after surgery)
研究者
Syed Nusrath
Basavatarakam Indo American Cancer Hospital and Research Institute