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

January 14, 2019 updated by: Yonsei University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Routine post-op care
Routine post-op care (N=20)
Other: Routine post-op care
Routine post-operative care
EXPERIMENTAL: Routine post-op care with Nutritional supplement
Routine post-op care + Nutritional supplement by specific product (N=20)
Dietary supplement: Postoperative Nutritional Supplement
Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)
Other Names:
  • NDKD

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 12, 2018

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (ACTUAL)

April 27, 2018

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

  • 4-2018-0166

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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