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

Yonsei University

Status: Completed

Conditions: Pancreaticobiliary Cancer; Ketogen-based Therapeutic Diet

Treatments: Dietary Supplement: Ordinary Diet; Dietary Supplement: Modified Atkin's Diet; Dietary Supplement: Ketogenic Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02964806

4-2016-0799

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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<90%)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Ordinary Diet

Other group

Description:

Ordinary Diet

Treatment:

Dietary Supplement: Ordinary Diet

Modified Atkin's Diet

Other group

Description:

Modified Atkin's Diet

Treatment:

Dietary Supplement: Modified Atkin's Diet

Ketogenic Diet

Other group

Description:

Ketogenic Diet

Treatment:

Dietary Supplement: Ketogenic Diet