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Effect of Meal on Portal and Esophagus Variceal Pressure (VIPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00485290
Recruitment Status : Terminated (No eligible patients were found, the study stopped without including any patients)
First Posted : June 12, 2007
Last Update Posted : August 7, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cirrhosis Esophageal Varices Behavioral: meal (food intake)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Meal on Portal and Esophagus Variceal Pressure
Study Start Date : June 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008


Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. effect of meal on variceal pressure [ Time Frame: 30 minutes after the meal ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485290


Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Director: Flemming Bendtsen, MD, DMsc. Hvidovre University Hospital
More Information

Responsible Party: Lise Hobolth, MD, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00485290     History of Changes
Other Study ID Numbers: H-KF-2007-0050
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: November 2007

Keywords provided by Hvidovre University Hospital:
cirrhosis, Portal Hypertension, Esophageal Varices, Meal

Additional relevant MeSH terms:
Fibrosis
Esophageal and Gastric Varices
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases