Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

Pancreaticobiliary Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964806
• Other study ID #: 4-2016-0799
• Status: Completed
• Phase: N/A
• First received: November 13, 2016
• Last updated: March 13, 2018
• Start date: November 7, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: March 2018
• 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 for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• 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<90%)

Related Conditions & MeSH terms

• Ketogen-based Therapeutic Diet
• Pancreaticobiliary Cancer

Intervention

Dietary Supplement:
• Ordinary Diet

• Modified Atkin's Diet

• Ketogenic Diet

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	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(%) will be examined by dietary satisfaction questionnaires.	3 days after the diet