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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
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cirrhosis focused on measuring cirrhosis, Portal Hypertension, Esophageal Varices, Meal

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 11, 2007
Last Updated
August 6, 2008
Sponsor
Hvidovre University Hospital
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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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