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Effect of Meal on Portal and Esophagus Variceal Pressure

NCT ID: NCT00485290

Last Updated: 2008-08-07

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

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-04-30

Brief Summary

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The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a meal on variceal pressure with a non invasive endoscopic measurement device, and compare it with portal pressure.

Detailed Description

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Conditions

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Cirrhosis Esophageal Varices

Keywords

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cirrhosis, Portal Hypertension, Esophageal Varices, Meal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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meal (food intake)

600 kcal. (16% protein, 49%carbohydrate, 35% fatt)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Large Esophageal varices

Exclusion Criteria

* Treatment with beta-blocking agents
* Respiratory diseases that contradict endoscopy
* Gastric-retention
* Former gastric resection
* Resent sclerotherapy or former banding
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hvidovre Hospital

Principal Investigators

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Flemming Bendtsen, MD, DMsc.

Role: STUDY_DIRECTOR

Hvidovre University Hospital

Locations

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Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-KF-2007-0050

Identifier Type: -

Identifier Source: org_study_id