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

This study has been terminated.
(No eligible patients were found, the study stopped without including any patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485290
First Posted: June 12, 2007
Last Update Posted: August 7, 2008
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.
Information provided by:
Hvidovre University Hospital
  Purpose
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 Intervention
Cirrhosis Esophageal Varices Behavioral: meal (food intake)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Meal on Portal and Esophagus Variceal Pressure

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

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

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: meal (food intake)
    600 kcal. (16% protein, 49%carbohydrate, 35% fatt)
  Eligibility

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 Submitted: June 11, 2007
First Posted: June 12, 2007
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