Effect of Meal on Portal and Esophagus Variceal Pressure

Cirrhosis Clinical Trial

— VIPE  

Official title:

Effect of Meal on Portal and Esophagus Variceal Pressure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00485290
• Other study ID #: H-KF-2007-0050
• Status: Terminated
• Phase: N/A
• First received: June 11, 2007
• Last updated: August 6, 2008
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2007
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal Varices

Intervention

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

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of meal on variceal pressure		30 minutes after the meal	No