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

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Yonsei University

Status

Enrolling

Conditions

Pancreaticobiliary Cancer

Treatments

Dietary Supplement: Postoperative Nutritional Supplement
Other: Routine post-op care

Study type

Interventional

Funder types

Other

Identifiers

NCT03510429
4-2018-0166

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 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.

Enrollment

40 estimated 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<70%)
  • Poor nutritional status (PG-SGA grade C)

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Routine post-op care
Active Comparator group
Description:
Routine post-op care (N=20)
Treatment:
Other: Routine post-op care
Routine post-op care with Nutritional supplement
Experimental group
Description:
Routine post-op care + Nutritional supplement by specific product (N=20)
Treatment:
Dietary Supplement: Postoperative Nutritional Supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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