NCT02626195

Preoperative Nutritional Support in Malnutritional Cancer Patients

Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer
• Biliary Cancer
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-11-27
• Completion: 2017-04-05
• First posted: 2015-12-10
• Last updated: 2018-06-11

Locations

1 site across 1 country: South Korea