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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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