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

Pancreaticobiliary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510429
• Other study ID #: 4-2018-0166
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: December 2023

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pancreaticobiliary Cancer

Intervention

Dietary Supplement:
• Postoperative Nutritional Supplement
Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)

Other:
• Routine post-op care
Routine post-operative care

Locations

Country	Name	City	State
Korea, Republic of	Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Intake Rate(%) for postoperative diet	Diet Intake Rate measured by dietary satisfaction questionnaire	1 day before operation
Primary	Food Intake Rate(%) for postoperative diet	Diet Intake Rate measured by dietary satisfaction questionnaire	3 days after food intake
Primary	Food Intake Rate(%) for postoperative diet	Diet Intake Rate measured by dietary satisfaction questionnaire	at the discharge date (8 weeks after operation)
Primary	Food Intake Rate(%) for postoperative diet	Diet Intake Rate measured by dietary satisfaction questionnaire	at the first follow up date (4 weeks after discharge)