Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- postoperative complication
研究概览
简要总结
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.
The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
详细描述
This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).
For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
- Calories: 30-35Kg, via enteral or parenteral
- Protein: 1.2-1.5g/Kg
- Lipid : 1-1.5g/Kg
- Mineral and vitamins supply
- Blood glucose control
- Daily monitoring by dietician and specialized nurse
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
- •Patients diagnosed with malnutrition (at least more than one)
- •PG-SGA B or C
- •Weight loss >10% within 6 month
- •Serum Albumin <3.0
- •Age less than 80 years old over 20 years old
- •Performance status (ECOG scale): 0-1
- •Adequate organ functions
- •Hb ≥7.0 g/dl
- •ANC ≥1,500/mm3
- •PLT ≥80,000/mm3
- •Liver function: AST/ALT ≤5×upper limit of normal
- •Creatinine ≤2.0 ULN
排除标准
- •Biopsy, drainage tube insertion, and other minor surgery
- •palliative surgery
- •Serious illness or medical conditions, as follows;
- •congestive heart failure (NYHA class III or IV)
- •unstable angina or myocardial infarction within the past 6 months,
- •significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- •uncontrolled hypertension
- •hepatic cirrhosis( ≥ Child class B)
- •interstitial pneumonia, pulmonary adenomatosis
- •psychiatric disorder that may interfere with and/or protocol compliance
- •unstable diabetes mellitus
- •uncontrolled ascites or pleural effusion
- •active infection
- •Any patients judged by the investigator to be unfit to participate in the study
研究组 & 干预措施
nutritional support program apply
Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.
干预措施: nutritional support program (Dietary Supplement)
historical control group
Historical control group is that did not receiving
结局指标
主要结局
postoperative complication
时间窗: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
expected the duration of hospital stay of postoperation is 4\~6 weeks.
次要结局
- quality of life(preoperative, postoperative 14days)
- postoperative cost( + nutritional support cost)(at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.))
- postoperative hospital stay(expected the duration of hospital stay of postoperation is 4~6 weeks.)
研究者
Sang-Jae Park
Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch
National Cancer Center, Korea