Skip to main content
OpenTrials
Completed

NCT Number: NCT03294096

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreaticobiliary Cancer

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Routine care + Nutritional product

Dietary Supplement

Routine post-op care + Nutritional supplement by specific product

Routine care

Other

Routine post-op care

Primary outcomes

  1. Food Intake Rate(%) for postoperative diet

    Time frame: Pre-operation

    Diet Intake Rate(%)

  2. Food Intake Rate(%) for postoperative diet

    Time frame: 1 day before discharging

    Diet Intake Rate(%)

  3. Food Intake Rate(%) for postoperative diet

    Time frame: 1 week after discharging (first outpatient follow up)

    Diet Intake Rate(%)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.