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NCT00635687 Clinical Trial

Transient Elastography and Variceal Bleeding

Bleeding Clinical Trial

— PROME  

Official title:
Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00635687
Other study ID # 2006/102/HP
Secondary ID
Status Terminated
Phase N/A
First received March 7, 2008
Last updated March 4, 2013
Start date March 2008
Est. completion date May 2012

Study information
Verified date March 2013
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.

Recruitment information / eligibility
Status Terminated
Enrollment 29
Est. completion date May 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Informed consent form signed

- Social security affiliation

- Variceal bleeding with hematemesis or melena within 24 hours of inclusion

- Age > 18 years

- Scheduled to undergo endoscopy within 24 hours of hospital admission

Exclusion Criteria:

- Hepatocarcinoma

- Upper Gastro Intestinal bleeding for other causes than variceal bleeding

- Concomitant disease with a life expectancy of less than 45 days

- Rebleeding within 24 hours after first endoscopy

- Technical failure of transient elastography

Study Design

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

Related Conditions & MeSH terms

Intervention

Device:
• Fibroscan
transient elastography measure - Liver stiffness

Locations
Country Name City State
France UH Amiens Amiens
France UH Caen Caen
France UH Lille Lille
France Rouen University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bleeding recurrence rate J45 post first hemorrage No
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