NCT00635687

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

4 years

First QC Date

March 7, 2008

Last Update Submit

March 4, 2013

Conditions

Bleeding

Keywords

variceal bleedingtransient elastography

Outcome Measures

Primary Outcomes (1)

  • Bleeding recurrence rate

    J45 post first hemorrage

Study Arms (1)

Fibroscan

EXPERIMENTAL
Device: Fibroscan

Interventions

FibroscanDEVICE

transient elastography measure - Liver stiffness

Fibroscan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent form signed
  • Social security affiliation
  • Age \> 18 years
  • Scheduled to undergo endoscopy within 24 hours of hospital admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UH Amiens

Amiens, 80054, France

Location

UH Caen

Caen, 14033, France

Location

UH Lille

Lille, 59000, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie HERVE, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

FR(4)