Clinical Validation of Nutritional Supplements(Ketogenic Plus) Developed for Pancreaticobiliary Cancer Patients

Study Overview
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Brief Summary
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Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. This time, newly developed ketogenic drink contain beefsteak mint. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

Official Title
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Clinical Validation of Nutritional Supplements(Ketogenic Plus) Developed for Pancreaticobiliary Cancer Patients

Conditions
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Pancreaticobiliary Cancer

Intervention / Treatment
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* Dietary Supplement: Postoperative Nutritional Supplement
* Other: Routine post-op care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age more than 19) Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer Exclusion Criteria: Patient who denied clinical trial Diabetes Mellitus(DM) patient with DM complication Hyperlipidemia patient with vascular co-morbidity Impaired renal function or renal failure (GFP<70%) Poor nutritional status (PG-SGA grade C)

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine post-op care<br>Routine post-op care (N=20) | Other: Routine post-op care<br>* Routine post-operative care<br>|
| Experimental: Routine post-op care with Nutritional supplement<br>Routine post-op care + Nutritional supplement by specific product (N=20) | Dietary Supplement: Postoperative Nutritional Supplement<br>* Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)<br>* Other names: NDKD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate measured by dietary satisfaction questionnaire | 1 day before operation | 
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate measured by dietary satisfaction questionnaire | 3 days after food intake | 
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate measured by dietary satisfaction questionnaire | at the discharge date (8 weeks after operation) | 
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate measured by dietary satisfaction questionnaire | at the first follow up date (4 weeks after discharge) |