Preliminary Study of Pediatric Diaphragmatic Elastography (ECHODIA)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Congenital Diaphragmatic Hernia

Treatments: Other: Ultrasonic elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT06666140

9420

2024-A01627-40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Group HDC:
• Patient followed at the CCMR (centres de compétence maladies rares) HDC of the Strasbourg University Hospital
• Aged between 3 and 17 years old inclusive
• Indifferent Sex
• Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
• Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
• Subject who has been informed of the results of the preliminary medical examination

Control group:

• Subject followed in pediatric surgery
• Aged between 3 and 17 years old inclusive
• Indifferent Sex
• Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
• Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
• Subject who has been informed of the results of the preliminary medical examination

Exclusion criteria

• Group HDC:

  • Refusal
  • Language barrier
  • Diaphragmatic surgery within the last 3 months
  • Patient with a viral picture in progress at the time of examination (assessment by the investigator)
  • Patient treated with muscle relaxant
  • Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
  • Subject under safeguard of justice
  • Subject under guardianship or curatorship
  • Pregnant or breastfeeding woman

Control group:

• Patient without thoracic pathology
• Refusal
• Language barrier
• Diaphragmatic pathology
• Any myopathy
• History of surgery of the upper digestive tract (esophagus and/or gastric and/or duodenal)
• Patient on muscle relaxant
• Patient with a viral picture in progress at the time of examination (assessment by the investigator)
• Patient treated with muscle relaxant
• Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under safeguard of justice
• Subject under guardianship or curatorship
• Pregnant or breastfeeding woman

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group HDC

Experimental group

Description:

40 children with diaphragmatic hernia with or without prosthesis (HDC)

Treatment:

Other: Ultrasonic elastography

Control Group

Other group

Description:

40 children free of any diaphragmatic pathology

Treatment:

Other: Ultrasonic elastography