National Cancer Center
Goyang-si, Gyeonggi-do, 410-769, South Korea
NCT Number: NCT02626195
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.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Goyang-si, Gyeonggi-do, 410-769, South Korea
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
Time frame: 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.
Time frame: expected the duration of hospital stay of postoperation is 4~6 weeks.
expected the duration of hospital stay of postoperation is 4~6 weeks.
Time frame: preoperative, postoperative 14days
preoperative, postoperative 14days
Time frame: 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.
Time frame: preoperative, postoperative 14days
CD4/CD8, immunoglobulin G, M, A
National Cancer Center, Korea
Other Gov
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
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