Transient Elastography and Variceal Bleeding

NCT ID: NCT00635687

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fibroscan

Group Type EXPERIMENTAL

Fibroscan

Intervention Type DEVICE

transient elastography measure - Liver stiffness

Interventions

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Fibroscan

transient elastography measure - Liver stiffness

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie HERVE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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UH Amiens

Amiens, , France

Site Status

UH Caen

Caen, , France

Site Status

UH Lille

Lille, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2006/102/HP

Identifier Type: -

Identifier Source: org_study_id

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