Diaphragmatic EventrationPedDiaVenNCT04862494
Diaphragmatic Eventration in Children : Evaluation of Care Strategies and Results in the French Cohort.
An observational study of Diaphragmatic Eventration, run by University Hospital, Angers.
Trial summary
A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Diaphragmatic Eventration
- What is being tested?
- clinical surveillance and diaphragmatic plication
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: National cohort of all pediatric patients diagnosed with or operated for diaphragmatic eventration since January, 1st, 2010, in a pediatric surgical care unit in France. Patients will be devided into non operated and operated patients for outcome comparisons.
Who may be able to join
- Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.
Who cannot join
- Patients with a diaphragmatic hernia
- Patient's parents or legual guardian opposed to being included in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.
A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy.
Most diaphragmatic eventrations are asymptomatic and discovered thanks to chest x-rays, where the diaphragmatic dome is elevated and visualized above the 4th intercostal space and sometimes up to the clavicle. Computed tomography or magnetic resonance imaging confirms the eventration by visualizing the diaphragmatic muscle distended and intact, unlike a diaphragmatic rupture or hernia.
Read more
Surgical indications are usually due to respiratory disorders or visceral repercussions, such as gastric emptying disorders or acute accidents like gastric volvulus. Surgical treatment is a phrenic plication, which can be performed via a lateral thoracotomy (classical approach), thoracoscopy or laparoscopy.
When surgery is not indicated, follow up consists of regular clinical and radiological monitoring.
There is, however, no consensus when it comes to their medical and surgical management due to the very low number of patients per center and per year, and the fact that very few studies specifically address this subject in the literature.
Read the detailed description
This is a retrospective multicenter descriptive cohort study based on French national healthcare data. The aim of this study is to describe the current trends in management of diaphragmatic eventrations in France in order to indentify potential risk factors for complications and to improve and homogenize practices.
- Conditions
- Diaphragmatic Eventration
- Being tested
- clinical surveillance, diaphragmatic plication
- Keywords
- thoracoscopy, laparoscopy, digestive disorders, restrictive syndrom
- Medical subject headings
- Diaphragmatic Eventration, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical surveillanceOther
regular clinical follow up including chest X-rays, pulmonary investigations, etc...
diaphragmatic plicationProcedure or surgery
plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| diaphragmatic eventation with medical surveillance | Patients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair. Receives: Other: clinical surveillance | |
| diaphragmatic eventration treated with plication | Patients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair. Receives: Procedure: diaphragmatic plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).
Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.
Measured: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Secondary outcomes (4)
To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations
Objectified by pulmonary function tests (PFTs), carried out according to the ATS/ERS-GLI (American Thoracic Society and European Respiratory Society-Global Lung Initiative) recommendations.
Measured: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the rate of digestive symptoms in patients with diaphragmatic eventrations.
Clinical assessment of digestive symptoms linked to diaphragmatic eventration and/or to diaphragmatic plication, such à GERD, dumping syndrom, digestive occlusion or pain (scored by visual analogic scale).
Measured: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrations
objectified by the deformation of the spine on chest x-ray measured by the Cobb angle.
Measured: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the severity rate of postoperative complications
Description of postoperative complications encountered after diaphragmatic plication, scored with the Clavien-Dindo classification.
Measured: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragmatic EventrationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume Podevin, MD-PhD, Study director, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862494
- Sponsor's protocol ID
- 2021-013
- Acronym
- PedDiaVen
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heng L, Alzahrani K, Montalva L, Podevin G, Schmitt F; PedDiaVen collaboration group. Congenital Diaphragmatic Eventration: Should we Maintain Surgical Treatment? A Retrospective Multicentric Cohort Study. J Pediatr Surg. 2025 Jan;60(1):161991. doi: 10.1016/j.jpedsurg.2024.161991. Epub 2024 Oct 10.
PubMed 39442326
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Treatment of Diaphragmatic Eventrations in France: Management Strategies and Long-term Results : an Observational Study.
- ClinicalTrials.gov ID
- NCT04862494
- Acronym / sponsor ID
- PedDiaVen / 2021-013
- Conditions
- Diaphragmatic Eventration
- Keywords
- thoracoscopy, laparoscopy, digestive disorders, restrictive syndrom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A diaphragmatic eventration is an abnormal and permanent elevation of a portion or an entire intact hemidiaphragm. This rare pathology, found in 0.2 - 1 for every 1000 patients in large radiological series, is either congenital or acquired due to phrenic nerve palsy.
Most diaphragmatic eventrations are asymptomatic and discovered thanks to chest x-rays, where the diaphragmatic dome is elevated and visualized above the 4th intercostal space and sometimes up to the clavicle. Computed tomography or magnetic resonance imaging confirms the eventration by visualizing the diaphragmatic muscle distended and intact, unlike a diaphragmatic rupture or hernia.
Surgical indications are usually due to respiratory disorders or visceral repercussions, such as gastric emptying disorders or acute accidents like gastric volvulus. Surgical treatment is a phrenic plication, which can be performed via a lateral thoracotomy (classical approach), thoracoscopy or laparoscopy.
When surgery is not indicated, follow up consists of regular clinical and radiological monitoring.
There is, however, no consensus when it comes to their medical and surgical management due to the very low number of patients per center and per year, and the fact that very few studies specifically address this subject in the literature.
Detailed description
This is a retrospective multicenter descriptive cohort study based on French national healthcare data. The aim of this study is to describe the current trends in management of diaphragmatic eventrations in France in order to indentify potential risk factors for complications and to improve and homogenize practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic eventation with medical surveillance | – | Other: clinical surveillancePatients with a diagnosis of diaphragmatic eventration without respiratory or digestive consequences, thus not requiring surgical repair. |
| diaphragmatic eventration treated with plication | – | Procedure: diaphragmatic plicationPatients with a diagnosis of diaphragmatic eventration with respiratory or digestive repercussion, requiring surgical repair. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- National cohort of all pediatric patients diagnosed with or operated for diaphragmatic eventration since January, 1st, 2010, in a pediatric surgical care unit in France. Patients will be devided into non operated and operated patients for outcome comparisons.
Key inclusion criteria (1 listed)
- Patients of 16 years of age and under at diagnosis with diaphragmatic eventration, treated since 2010 in a pediatric surgery care unit in France.
Key exclusion criteria (2 listed)
- Patients with a diaphragmatic hernia
- Patient's parents or legual guardian opposed to being included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical surveillanceregular clinical follow up including chest X-rays, pulmonary investigations, etc... | Other | diaphragmatic eventation with medical surveillance |
| diaphragmatic plicationplication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy | Procedure or surgery | diaphragmatic eventration treated with plication |
Primary outcome
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not).
Time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Asymptomatic patient rate defined as patients presenting without any digestive, respiratory or orthopaedic symptom.
4 secondary outcomes
To assess the occurrence of lung disease in patients with non treated diaphragmatic eventrations
Time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the rate of digestive symptoms in patients with diaphragmatic eventrations.
Time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the occurrence of orthopaedic impact of non treated diaphragmatic eventrations
Time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
To assess the severity rate of postoperative complications
Time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 39442326Heng L, Alzahrani K, Montalva L, Podevin G, Schmitt F; PedDiaVen collaboration group. Congenital Diaphragmatic Eventration: Should we Maintain Surgical Treatment? A Retrospective Multicentric Cohort Study. J Pediatr Surg. 2025 Jan;60(1):161991. doi: 10.1016/j.jpedsurg.2024.161991. Epub 2024 Oct 10.
- Individual participant dataSharing planned: No
Related trials for Diaphragmatic Eventration
RecruitingObservational study
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
Gastroschisis, Congenital Diaphragmatic Hernia
Not yet recruitingObservational study
Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis
Diaphragmatic Plication, Diaphragmatic Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Podevin, MD-PhD study director
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragmatic Eventration, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Françoise Schmitt, MD-PhD (+33241354290, FrSchmitt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the level of asymptomatic patients diagnosed with diaphragmatic eventration depending on the type of treatment (surgical or not). (time frame: Up to 16 years of age. From the date of diagnosis until the date of last check-up, assessed up to 16 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.