Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-03-09 @ 4:10 AM
Study NCT ID:
NCT02626195
Status:
COMPLETED
Last Update Posted:
2018-06-11
First Post:
2015-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Nutritional Support in Malnutritional Cancer Patients
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: