Effect of Meal on Portal and Esophagus Variceal Pressure (VIPE)
Primary Purpose
Cirrhosis, Esophageal Varices
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
meal (food intake)
Sponsored by
About this trial
This is an interventional basic science trial for Cirrhosis focused on measuring cirrhosis, Portal Hypertension, Esophageal Varices, Meal
Eligibility 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
Sites / Locations
- Hvidovre Hospital
Outcomes
Primary Outcome Measures
effect of meal on variceal pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT00485290
First Posted
June 11, 2007
Last Updated
August 6, 2008
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00485290
Brief Title
Effect of Meal on Portal and Esophagus Variceal Pressure
Acronym
VIPE
Official Title
Effect of Meal on Portal and Esophagus Variceal Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Terminated
Why Stopped
No eligible patients were found, the study stopped without including any patients
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Esophageal Varices
Keywords
cirrhosis, Portal Hypertension, Esophageal Varices, Meal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
meal (food intake)
Intervention Description
600 kcal. (16% protein, 49%carbohydrate, 35% fatt)
Primary Outcome Measure Information:
Title
effect of meal on variceal pressure
Time Frame
30 minutes after the meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Bendtsen, MD, DMsc.
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Effect of Meal on Portal and Esophagus Variceal Pressure
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