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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00485290
Other study ID # H-KF-2007-0050
Secondary ID
Status Terminated
Phase N/A
First received June 11, 2007
Last updated August 6, 2008
Start date June 2007
Est. completion date April 2008

Study information

Verified date November 2007
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
meal (food intake)
600 kcal. (16% protein, 49%carbohydrate, 35% fatt)

Locations

Country Name City State
Denmark Hvidovre Hospital Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary effect of meal on variceal pressure 30 minutes after the meal No
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