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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03510429
Enrollment
40
Registered
2018-04-27
Start date
2018-04-12
Completion date
2023-12-31
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticobiliary Cancer

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.

Interventions

DIETARY_SUPPLEMENTPostoperative Nutritional Supplement

Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)

OTHERRoutine post-op care

Routine post-operative care

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Food Intake Rate(%) for postoperative diet1 day before operationDiet Intake Rate measured by dietary satisfaction questionnaire

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026