Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

NCT ID: NCT03294096

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-07-11

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreaticobiliary Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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experimental group

Group Type EXPERIMENTAL

Routine care + Nutritional product

Intervention Type DIETARY_SUPPLEMENT

Routine post-op care + Nutritional supplement by specific product

control group

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Routine post-op care

Interventions

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Routine care + Nutritional product

Routine post-op care + Nutritional supplement by specific product

Intervention Type DIETARY_SUPPLEMENT

Routine care

Routine post-op care

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2017-0625

Identifier Type: -

Identifier Source: org_study_id

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