Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary

Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

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https://clinicaltrials.gov/ct2/show/NCT03294096

PurposeDecreased 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. 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.

Condition
Intervention
Pancreaticobiliary Cancer
Dietary Supplement: Routine care + Nutritional productOther: Routine care

Study Type:
Interventional
Study Design:
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title:
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:Food Intake Rate(%) for postoperative diet [ Time Frame: Pre-operation ]Diet Intake Rate(%)

Food Intake Rate(%) for postoperative diet [ Time Frame: 1 day before discharging ]Diet Intake Rate(%)

Food Intake Rate(%) for postoperative diet [ Time Frame: 1 week after discharging (first outpatient follow up) ]Diet Intake Rate(%)

Estimated Enrollment:
30
Actual Study Start Date:
August 28, 2017
Estimated Study Completion Date:
December 2018
Estimated Primary Completion Date:
December 2018 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: experimental group
Dietary Supplement: Routine care + Nutritional productRoutine post-op care + Nutritional supplement by specific product
Active Comparator: control group
Other: Routine careRoutine post-op care

Eligibility
Information from the National Library of Medicine

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Ages Eligible for Study:
19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Criteria
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)
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294096

Locations

Korea, Republic of
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Recruiting
Seoul, Korea, Republic of, 03722
Contact: Chang Moo Kang, MD, Ph.D    82-2-2228-2120    cmkang@yuhs.ac
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT03294096     History of Changes
Other Study ID Numbers:
4-2017-0625

First Submitted:
September 18, 2017
First Posted:
September 26, 2017
Last Update Posted:
September 26, 2017
Last Verified:
September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided

Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No