Preoperative Nutritional Support in Malnutritional Cancer Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients

Conditions
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Pancreatic Cancer, Biliary Cancer, Malnutrition

Intervention / Treatment
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* Dietary Supplement: nutritional support program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects in anticipating major surgery of hepatobiliary pancreatic cancer Patients diagnosed with malnutrition (at least more than one) PG-SGA B or C Weight loss >10% within 6 month BMI <18.5 Serum Albumin <3.0 Age less than 80 years old over 20 years old Performance status (ECOG scale): 0-1 Adequate organ functions Hb ≥7.0 g/dl ANC ≥1,500/mm3 PLT ≥80,000/mm3 Liver function: AST/ALT ≤5×upper limit of normal Creatinine ≤2.0 ULN Exclusion Criteria: Biopsy, drainage tube insertion, and other minor surgery palliative surgery Serious illness or medical conditions, as follows; congestive heart failure (NYHA class III or IV) unstable angina or myocardial infarction within the past 6 months, significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block uncontrolled hypertension hepatic cirrhosis( ≥ Child class B) interstitial pneumonia, pulmonary adenomatosis psychiatric disorder that may interfere with and/or protocol compliance unstable diabetes mellitus uncontrolled ascites or pleural effusion active infection Pregnancy Any patients judged by the investigator to be unfit to participate in the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional support program apply<br>Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program. | Dietary Supplement: nutritional support program<br>* 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<br>|
| No Intervention: historical control group<br>Historical control group is that did not receiving | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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.) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery