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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:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00485290
First received: June 11, 2007
Last updated: August 6, 2008
Last verified: November 2007
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lise Hobolth, MD, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00485290     History of Changes
Other Study ID Numbers: H-KF-2007-0050
Study First Received: June 11, 2007
Last Updated: August 6, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on November 20, 2014