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

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ClinicalTrials.gov Identifier: NCT03510429
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Pancreaticobiliary Cancer Dietary Supplement: Postoperative Nutritional Supplement Other: Routine post-op care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Validation of Nutritional Supplements("Ketogenic Plus") Developed for Pancreaticobiliary Cancer Patients
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: NDKD




Primary Outcome Measures :
  1. Food Intake Rate(%) for postoperative diet [ Time Frame: 1 day before operation ]
    Diet Intake Rate measured by dietary satisfaction questionnaire

  2. Food Intake Rate(%) for postoperative diet [ Time Frame: 3 days after food intake ]
    Diet Intake Rate measured by dietary satisfaction questionnaire

  3. Food Intake Rate(%) for postoperative diet [ Time Frame: at the discharge date (8 weeks after operation) ]
    Diet Intake Rate measured by dietary satisfaction questionnaire

  4. 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



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
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)

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): NCT03510429


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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03510429     History of Changes
Other Study ID Numbers: 4-2018-0166
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
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