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

Yonsei University

Status: Unknown

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)

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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