Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

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. 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.

Study Overview

• Status: Completed
• Conditions: Pancreaticobiliary Cancer
• Intervention / Treatment: Dietary supplement: Routine care + Nutritional product; Other: Routine care

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Dietary supplement: Routine care + Nutritional product; Routine post-op care + Nutritional supplement by specific product
Active Comparator: control group	Other: Routine care; Routine post-op care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	Pre-operation
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	1 day before discharging
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%)	1 week after discharging (first outpatient follow up)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Actual): July 11, 2018
• Study Completion (Actual): July 11, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4-2017-0625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No