Comparison of Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis (MUCO-FIBRO)
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|ClinicalTrials.gov Identifier: NCT02342964|
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : December 21, 2017
Non-invasive methods of the quantification of fibrosis may help to assess the development of fibrosis at a specific moment of the evolution of the disease, in the order to decide the initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic cirrhosis:
- The ultrasound impulse elastography, Fibroscan (FS)
- Ultrasound Elastography by ShearWave (SWE)
- Magnetic resonance elastography (MRE). The purpose of this study is to assess the contribution of these methods in the diagnosis of hepatic fibrosis during the evolution of the cystic fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Other: Measure of hepatic elasticity||Not Applicable|
The incidence of hepatobiliary disease in cystic fibrosis in the first 10 years of life is 2.5 to 1.8 / 100 patient-years, significantly decreasing during the second decade; generally 30-40% of children develop hepatic disease before 12 years. However, the hepatobiliary damage varies in its clinical and histological expression. The typical histological appearance of the liver is the focal biliary cirrhosis (or fibrosis) characterized by a heterogeneous distribution of portal fibrosis in the liver.
Complications of cirrhosis are responsible for 2.5% of deaths in patients with cystic fibrosis and represent the second cause of death after lung disease if we exclude deaths secondary to lung transplantation.
The diagnosis of hepatic disease at an early stage of development and the assessment of the progression of fibrosis are so difficult in the absence of sensitive and specific non-invasive diagnostic tests.
Non-invasive assessment of hepatic fibrosis is an important topic of study in recent years, because of the emergence of biological methods and quantitative elastography methods using ultrasound or Magnetic Resonance Imagery (MRI) and allowing quantification of the hepatic elasticity, which is assumed to be a reflection of fibrosis. The advantages of these methods are numerous:
- The assessment of wider hepatic parenchyma then hepatic biopsy, allowing overcome the sampling bias
- Painless and non-invasive methods for the patient
- Simple to make
- Do not require hospitalization and can be performed as outpatient
- Immediately known results
- Can be repeated as often as necessary during the patient's follow-up
- Lower cost, morbidity and mortality compared to hepatic biopsy. Several non-invasive methods of fibrosis diagnosis have been studied in adults primarily for viral diseases and helped to limit the indications of hepatic biopsy. However, no method is now validated for the early diagnosis of hepatic disease and monitoring of children with cystic fibrosis.
The main objective of the study is to assess the contribution of FibroTest, the ultrasound impulse elastography, Fibroscan (FS), the ultrasound elastography by ShearWave (SWE) and Magnetic Resonance Elastography (MRE ) in the diagnosis of hepatic fibrosis in cystic fibrosis.
The secondary objectives are following :
- To study the correlations between the fibrosis quantitative results obtained through the four techniques of measurement and the matches between the results of four techniques using the standards available at t0 and after a year (t1).
- Study the correlations between clinical, biological and ultrasound endpoints of hepatic disease and various non-invasive measurement methods of fibrosis.
- Evaluate the area under the ROC curve of the different tests and the diagnostic performance tests using analytical methods without gold standard by classifying the children into two groups: the presence of advanced fibrosis (stages F2 to F4 ) or not (F0 and F1 stages), contracting by a committee according to the results of any biopsy, clinical, laboratory and ultrasound endpoints independent on the tests.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of Different Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis|
|Actual Study Start Date :||January 8, 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
Measures of hepatic elasticity
Other: Measure of hepatic elasticity
Measure of hepatic elasticity by four non-invasive methods:
Fibroscan, Fibrotest, SWE, MRE.
- Measure of hepatic elasticity by Fibro Test [ Time Frame: Day 0 ]The value of hepatic elasticity measured by each of the tests performed on the same day in the same patient
- Measure of hepatic elasticity by the ultrasound impulse elastography, Fibroscan (FS) [ Time Frame: Month 12 ]The value of hepatic elasticity measured by each of the tests performed on the same day in the same patient.
- Measure of hepatic elasticity by Ultrasound Elastography by ShearWave (SWE): [ Time Frame: Day 0 ]The existence of advanced hepatic fibrosis (stages F2 to F4) will be defined by the presence of clinical, and / or biological and / or ultrasound abnormalities, defining two groups of children (F + :children with advanced fibrosis, F-: children with little or no fibrosis
- Measure of hepatic elasticity by Magnetic resonance elastography (MRE): [ Time Frame: Month 12 ]The existence of advanced hepatic fibrosis (stages F2 to F4) will be defined by the presence of clinical, and / or biological and / or ultrasound abnormalities, defining two groups of children (F + :children with advanced fibrosis, F-: children with little or no fibrosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342964
|Contact: Dominique Debray, MD||00 33 1 44 49 41 firstname.lastname@example.org|
|Contact: Laurence Lecomte, PhD||+33 1 71 19 64 email@example.com|
|Paris, France, 75015|
|Contact: Dominique Debray, Md, PhD 00 33 1 44 49 41 52 firstname.lastname@example.org|
|Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 email@example.com|
|Principal Investigator:||Dominique Debray, MD, PhD||00 33 1 44 49 41 52|