Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis (PEDISCAN)
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Purpose
Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive method. If the elastometry method is proved to be a good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.
| Condition | Intervention |
|---|---|
|
Cirrhosis Liver Fibrosis Portal Hypertension Cystic Fibrosis Cholestasis of Parenteral Nutrition |
Other: Elastometry |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
| Official Title: | Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN. |
- To study the diagnosis value of hepatic elasticity measured by FIBROSCANN ® about fibrosis degree in comparison with hepatic biopsy (GOLDSTANDART) in a paediatric hepatic diseases cohort. [ Time Frame: until two months ] [ Designated as safety issue: No ]
- For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias. [ Time Frame: two months ] [ Designated as safety issue: No ]
- For a best follow-up of the fibrosis to optimize the treatment. [ Time Frame: two months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Fibrosis group
a single arm with the two interventions (elastometry and biopsy)
|
Other: Elastometry
Fibrosis detection with FIBROSCANN
Other Name: Elastometry
|
Detailed Description:
The elastometry method is proved to be efficient for the evaluation of liver fibrosis in adults. But the inter-costal space is too thin in children, and the adult probe could not be used. Recently a special probe adapted to the children have been TECHNICATED. We want to test this specific probe in children. Five French Paediatrics centres will participate to the study. We need 200 children inclusions in 2 years to have a statistically power analysis. Inclusion of each child will be in order to the need of a liver biopsy. Each children included will have an elastometry measure in the same time than the liver biopsy. The fibrosis will be staged by a trained pathologist and scored by METAVIR score witch is the reference. The elastometry measure will be realised by physician with 3 sequential measures in each child. The statistical analysis will be performed by statistician. If elastometry is proved to be an efficient method to evaluate the liver fibrosis in children, a numerous of liver biopsy could be avoided. Because elastometry is a non invasive method it could also be used as follow-up in different categories of children who needs sequential liver biopsy.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Children age more than 6 months and under 18 years old.
- Children with an hepatic biopsy for any fibrosis hepatitic diseases
- Clinical examination by a physician
Exclusion criteria :
- Children of less than 6 months and more than 18 years old.
- Pregnant women.
- No written informed consent
- No social security
Contacts and Locations| Contact: Muriel Girard, MD, PhD | 0033144494226 | muriel.girard@nck.aphp.fr |
| Contact: Laurence Lecomte, PhD | 0033158413545 | laurence.lecomte@cch.aphp.fr |
| France | |
| Necker Hospital | Recruiting |
| Paris, France, 75015 | |
| Principal Investigator: Florence Lacaille, MD, PhD | |
| Principal Investigator: | Florence Lacaille, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01072721 History of Changes |
| Other Study ID Numbers: | P081207, 2009-A00738-49 |
| Study First Received: | February 19, 2010 |
| Last Updated: | April 10, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Liver Fibrosis Elastometry FIBROSCANN Children |
Additional relevant MeSH terms:
|
Cholestasis Cystic Fibrosis Fibrosis Hypertension Hypertension, Portal Liver Cirrhosis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
Pancreatic Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Vascular Diseases Cardiovascular Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 19, 2013