Biliary Cancer, Malnutrition, Pancreatic Cancer
Conditions
Keywords
malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTnutritional 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
Sponsors
Fresenius Kabi
National Cancer Center, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer 2. Patients diagnosed with malnutrition (at least more than one) 1. PG-SGA B or C 2. Weight loss \>10% within 6 month 3. BMI \<18.5 4. Serum Albumin \<3.0 3. Age less than 80 years old over 20 years old 4. Performance status (ECOG scale): 0-1 5. Adequate organ functions 1. Hb ≥7.0 g/dl 2. ANC ≥1,500/mm3 3. PLT ≥80,000/mm3 4. Liver function: AST/ALT ≤5×upper limit of normal 5. Creatinine ≤2.0 ULN
Exclusion criteria
1. Biopsy, drainage tube insertion, and other minor surgery 2. palliative surgery 3. Serious illness or medical conditions, as follows; 1. congestive heart failure (NYHA class III or IV) 2. unstable angina or myocardial infarction within the past 6 months, 3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block 4. uncontrolled hypertension 5. hepatic cirrhosis( ≥ Child class B) 6. interstitial pneumonia, pulmonary adenomatosis 7. psychiatric disorder that may interfere with and/or protocol compliance 8. unstable diabetes mellitus 9. uncontrolled ascites or pleural effusion 10. active infection 4. Pregnancy 5. Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hospital stay | expected the duration of hospital stay of postoperation is 4~6 weeks. | expected the duration of hospital stay of postoperation is 4\ 6 weeks. |
| quality of life | preoperative, postoperative 14days | preoperative, postoperative 14days |
| postoperative cost( + nutritional support cost) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| immunologic change(CD4/CD8) after nutritional support | preoperative, postoperative 14days | CD4/CD8, immunoglobulin G, M, A |
Countries
South Korea
Outcome results
None listed