Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

Not Applicable

Completed

• Conditions: Ketogen-based Therapeutic Diet; Pancreaticobiliary Cancer
• Interventions: Dietary Supplement: Modified Atkin's Diet; Dietary Supplement: Ketogenic Diet; Dietary Supplement: Ordinary Diet

• Registration Number: NCT02964806
• 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 for pancreaticobiliary cancer patients. The investigators expect that customized diets 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: 2016-11-07
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-13
• Study First Posted: 2016-11-16
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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<90%)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modified Atkin's Diet	Modified Atkin's Diet	Modified Atkin's Diet
Ketogenic Diet	Ketogenic Diet	Ketogenic Diet
Ordinary Diet	Ordinary Diet	Ordinary Diet

Primary Outcome Measures

Name	Time	Method
Food Intake Rate(%) for postoperative diet	3 days after the diet	Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of