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

NCT03510429 | Unknown DMC

• 1 other identifier: 4-2018-0166
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreaticobiliary Cancer

Outcome Measures

Primary Outcomes (4)

• Food Intake Rate(%) for postoperative diet

  Diet Intake Rate measured by dietary satisfaction questionnaire

  1 day before operation

• Food Intake Rate(%) for postoperative diet

  Diet Intake Rate measured by dietary satisfaction questionnaire

  3 days after food intake

• Food Intake Rate(%) for postoperative diet

  Diet Intake Rate measured by dietary satisfaction questionnaire

  at the discharge date (8 weeks after operation)

• Food Intake Rate(%) for postoperative diet

  Diet Intake Rate measured by dietary satisfaction questionnaire

  at the first follow up date (4 weeks after discharge)

Study Arms (2)

Routine post-op care

ACTIVE COMPARATOR

Routine post-op care (N=20)

Other: Routine post-op care

Routine post-op care with Nutritional supplement

EXPERIMENTAL

Routine post-op care + Nutritional supplement by specific product (N=20)

Dietary Supplement: Postoperative Nutritional Supplement

Interventions

Postoperative Nutritional Supplement DIETARY_SUPPLEMENT

Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)

Also known as: NDKD

Routine post-op care with Nutritional supplement

Routine post-op care OTHER

Routine post-operative care

Routine post-op care

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: April 12, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

KR (1)