Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

NCT ID: NCT02319252

Last Updated: 2018-04-20

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-04-30

Brief Summary

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The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake.

The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea \& vomiting.

The study will include 40 patients at Aarhus University Hospital, Denmark.

Detailed Description

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Conditions

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Malnutrition Liver Diseases, Alcoholic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric tube

A gastric tube is used

Group Type ACTIVE_COMPARATOR

Gastric tube (Nutricia Flocare® Pur Tube Enlock)

Intervention Type DEVICE

Nutricia Flocare® Pur Tube Enlock, Ch. 12

Jejunal tube

A jejunal tube is used

Group Type ACTIVE_COMPARATOR

Jejunal tube (Nutricia Flocare® Bengmark®)

Intervention Type DEVICE

Nutricia Flocare® Bengmark®, Ch. 10

Interventions

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Gastric tube (Nutricia Flocare® Pur Tube Enlock)

Nutricia Flocare® Pur Tube Enlock, Ch. 12

Intervention Type DEVICE

Jejunal tube (Nutricia Flocare® Bengmark®)

Nutricia Flocare® Bengmark®, Ch. 10

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Alcoholic liver disease
* nutrition intake less than 75% of needed intake
* Signed informed consent form

Exclusion Criteria

* Hepatic encephalopathy, grade 3 - 4
* Anatomic barriers to have a tube placed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Palle Bager, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Denmark

Locations

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Aarhus University Hospital

Aarhus, Central Region, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Tubes in liver diseases

Identifier Type: -

Identifier Source: org_study_id

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