Transient Elastography and Variceal Bleeding (PROME)

University Hospital, Rouen

Status: Terminated

Conditions: Bleeding

Treatments: Device: Fibroscan

Study type: Interventional

Funder types: Other

Identifiers

NCT00635687

2006/102/HP

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Fibroscan

Experimental group

Treatment:

Device: Fibroscan