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

Not Applicable

• Conditions: Pancreaticobiliary Cancer
• Interventions: Other: Routine post-op care; Dietary Supplement: Postoperative Nutritional Supplement

• Registration Number: NCT03510429
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-12
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-04-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Routine post-op care	Routine post-op care	Routine post-op care (N=20)
Routine post-op care with Nutritional supplement	Postoperative Nutritional Supplement	Routine post-op care + Nutritional supplement by specific product (N=20)

Primary Outcome Measures

Name	Time	Method
Food Intake Rate(%) for postoperative diet	at the first follow up date (4 weeks after discharge)	Diet Intake Rate measured by dietary satisfaction questionnaire

Trial Locations

Locations (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of