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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01627-40 | Other Identifier | ANSM |
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This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group of patients without a history of hernia.
The hypothesis is to be able to correlate the values found with the patients' symptomatology and thus to better monitor patients by a simple, accessible, painless and reproducible diagnostic tool, to better understand their evolution and even to be able to anticipate possible difficulties (reflux, respiratory disorders, scoliosis, etc.).
Ultrasound elastography is a recent and clinically recognized method that uses an ultrasound approach to determine tissue stiffness in a non-invasive way.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group HDC | Experimental | 40 children with diaphragmatic hernia with or without prosthesis (HDC) |
|
| Control Group | Other | 40 children free of any diaphragmatic pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic elastography | Other | The measurement of diaphragmatic stiffness by shear waves is performed with a high-frequency linear ultrasound probe, intercostally, during apneas lasting a few seconds. After quantitative diaphragm thickness measurements, the ultrasound probe positioning is unchanged and regions of interest are placed in the patient's diaphragm thickness as well as in the adjacent liver or spleen (baseline). A stiffness result is obtained in kPa. The elastography measurement extends the duration of the ultrasound scheduled as part of patient care by only 10 minutes. The examination is painless and non-invasive. |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology. | Diaphragmatic rigidity in ultrasound elastographic analysis: measurement of diaphragm stiffness in shear wave elastography, in apnea (measurement in kPa). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. | Bilateral measurements for each subject of the diaphragm performed in mode B, Intercostal analysis in mode B | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the association between the absence of the prosthesis and the symptomatology of patients in HDC subjects | Collection of the presence of a prosthesis and the various symptoms | Baseline |
| To estimate the difference in diaphragmatic mobility between a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia |
Inclusion Criteria:
Control group:
Exclusion Criteria:
Group HDC:
Control group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle TALON | Contact | +33388127296 | Professor | isabelle.TALON@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle TALON, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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|
| To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. |
Bilateral measurements for each subject of the diaphragm made in elastography. |
| Baseline |
| To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. | Bilateral measurements for each subject of the diaphragm made in TM mode, Analysis in M mode (time-movement). | Baseline |
| To evaluate the correlation between age and the different parameters measured by ultrasound (on the total population and then within the 3 groups: no hernia, hernia with plaque, hernia without plaque) | Collection of age and the various parameters measured by ultrasound (diaphragmatic thickness and rigidity). | Baseline |
| To estimate the association between patient stiffness and symptomatology in HDC subjects. | Measurement of rigidity and collection of symptoms | Baseline |
Measurement of diaphragmatic mobility in a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia |
| Baseline |
| To estimate the difference in pyloric position between a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia | Evaluation of the position of the pyloric (in strict axial section passing through the hepatic hilum, pylora normally visible. Estimate its position in cm (cranio caudal) in relation to the hilum if not in place) in a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia | Baseline |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |