Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

NCT ID: NCT02964806

Last Updated: 2018-03-15

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2017-10-01

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 for pancreaticobiliary cancer patients. The investigators expect that customized diets 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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Ketogen-based Therapeutic Diet 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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Ordinary Diet

Ordinary Diet

Group Type OTHER

Ordinary Diet

Intervention Type DIETARY_SUPPLEMENT

Modified Atkin's Diet

Modified Atkin's Diet

Group Type OTHER

Modified Atkin's Diet

Intervention Type DIETARY_SUPPLEMENT

Ketogenic Diet

Ketogenic Diet

Group Type OTHER

Ketogenic Diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ordinary Diet

Intervention Type DIETARY_SUPPLEMENT

Modified Atkin's Diet

Intervention Type DIETARY_SUPPLEMENT

Ketogenic Diet

Intervention Type DIETARY_SUPPLEMENT

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\<90%)
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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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2016-0799

Identifier Type: -

Identifier Source: org_study_id

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