Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutritional support program apply | Experimental | Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program. |
|
| historical control group | No Intervention | Historical control group is that did not receiving |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional support program | Dietary Supplement | Nutritional support program is briefly described below. Interval: 5-10 days Contents: admission is required
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication | expected the duration of hospital stay of postoperation is 4~6 weeks. | at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| immunologic change(CD4/CD8) after nutritional support | CD4/CD8, immunoglobulin G, M, A | preoperative, postoperative 14days |
Inclusion Criteria:
Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
Patients diagnosed with malnutrition (at least more than one)
Age less than 80 years old over 20 years old
Performance status (ECOG scale): 0-1
Adequate organ functions
Exclusion Criteria:
Biopsy, drainage tube insertion, and other minor surgery
palliative surgery
Serious illness or medical conditions, as follows;
Pregnancy
Any patients judged by the investigator to be unfit to participate in the study
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SangJae Park | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| preoperative, postoperative 14days |
| postoperative cost( + nutritional support cost) | expected the duration of hospital stay of postoperation is 4~6 weeks. | at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |