Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases

Not Applicable

Completed

• Conditions: Malnutrition; Liver Diseases, Alcoholic
• Interventions: Device: Gastric tube (Nutricia Flocare® Pur Tube Enlock); Device: Jejunal tube (Nutricia Flocare® Bengmark®)

• Registration Number: NCT02319252
• Lead Sponsor: University of Aarhus

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-18
• Study Start: 2015-01
• Status Verified: 2016-05
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

• Hepatic encephalopathy, grade 3 - 4
• Anatomic barriers to have a tube placed

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric tube	Gastric tube (Nutricia Flocare® Pur Tube Enlock)	A gastric tube is used
Jejunal tube	Jejunal tube (Nutricia Flocare® Bengmark®)	A jejunal tube is used

Primary Outcome Measures

Name	Time	Method
Differences in nutrition intake	Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months	Nutrition intake, protein intake, oral intake versus tube intake

Secondary Outcome Measures

Name	Time	Method
Differences in patients reported outcomes	Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months	Questionnaires

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Region, Denmark