Pancreaticobiliary Cancer Clinical Trial
Official title:
Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients
Verified date | January 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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) |
Status | Clinical Trial | Phase | |
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Completed |
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