Esophageal AtresiaRestriMISNCT04136795
Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
An observational study of Esophageal Atresia and Oesophageal Atresia, run by University Hospital, Angers at 1 site in France.
Trial summary
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Atresia, Oesophageal Atresia, Restrictive Lung Disease
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients included in the national esophageal atresia registry (CRACMO) having had an operation for type III esophageal atresia, as defined by the Ladd classification between 01/01/2008 and 31/12/2013 and being followed up with thoracic X-rays and PFTs.
Who may be able to join
- Patients included in the national esophageal atresia registry (CRACMO)
- Operation for type III esophageal atresia (Ladd classification)
- Between 01/01/2008 and 31/12/2013.
Who cannot join
- Long gap esophageal atresia
- Patients lost to follow up
- Deceased
- No PFTs or X-rays between 6 and 9 years of follow up
- Patients having had thoracic surgery before the esophageal atresia repair
Trial locations and contacts
1 site in 1 country.
France1 site
CRACMO - centre de référence des atrésies de l'oesophage
Lille, 59000
Rony Sfeir, MD, +33 3 20 44 59 62, Rony.SFEIR@CHRU-LILLE.FR
About this study
Official title: Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be he occurrence of restrictive lung disease , objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
Read the detailed description
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be the occurrence of restrictive lung disease, as assessed by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
The secondary endpoints will be to measure the severity of the restrictive disease, to look for other respiratory alterations, to correlate radiological chest wall sequelae anomalies with the impact on respiratory function and to look for a causal relationship between the surgical technique used and the respiratory impact.
The methodology used will be a retrospective non interventional study on the cohort of patients included in the national esophageal atresia registry (CRACMO, Lille University Hospital) between the 1st of january 2008 and the 31st of December 2013.
All the patients included in the national esophageal atresia registry (CRACMO) having had an operation for type III esophageal atresia (long gap esophageal atresia excluded), as defined by the Ladd Classification, will be included in this study.
The exclusion criterion will be patients lost to follow up or deceased, patients having had no pulmonary function tests (PFTs) or no thoracic X-Ray during the first 6 to 9 years of follow up and patients having had thoracic surgery before the esophageal atresia repair.
The number of patients expected in the national esophageal atresia registry over the 6 years excedes 500. The number of thoracoscopy repairs should be about 50.
This study should allow us to determine if minimally invasive surgery is beneficial on mid-term respiratory function in children, related to possible post-operative chest wall sequelae.
The results obtained from this study should lead to recommendations concerning the surgical approach to esophageal atresia repair to improve the prognosis of chest wall anomalies and respiratory function in these patients. It should also help to identify patient subgroups which would benefit from a reinforced respiratory follow up. This could then lead to a hospital clinical research program (PHRC)
- Keywords
- esophageal atresia, thoracoscopy, rib fusion, scoliosis, Respiratory function
- Medical subject headings
- Esophageal Atresia, Scoliosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery | Patients having had esophageal atresia (type III, long gap excluded) repair by conventional surgery (right thoracotomy) or patients having had minimally invasive surgery converted to thoracotomy between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) | |
| Minimally invasive surgery | Patients having had esophageal atresia (type III, long gap excluded) repair through minimally invasive surgery between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
Objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines. Restrictive lung disease defined by: FEV1/FVC ratio > -1.64 Z-score and CVF < -1.64 Z-score according to ATS/ERS-GLI (American Thoracic Society \& European Respiratory Society - Global Lungs Initiative) recommendations.
Measured: 6 to 9 years of age.
Secondary outcomes (6)
Severity of restrictive lung disease
Depending on Z-score value
Measured: 6 to 9 years of age
Assesse the occurrence of obstructive or mixed lung disease
Objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines. Mixed lung disease defined by: FEV1/FVC ratio < -1.64 Z-score and CVF < -1.64 Z-score and obstructive lung disease
Measured: 6 to 9 years
Mortality rate
Percentage of mortality in each group, cause of death linked directly to surgery or not
Measured: Time of surgery to 6 to 9 years consultation
Percentage of post-operative complications depending on the type of surgery
Bleeding, infection, anastomotic stenosis, anastomotic leak
Measured: Time of surgery to 6 to 9 years consultation
Chest wall anomalies detected on thoracic X-rays
Hemivertebra, rib fusion, intercostal abnormalities, scoliosis
Measured: 6 to 9 years of age
Correlation between post-operative chest wall anomalies and restrictive lung disease
In each group, comparison of the percentage of chest wall anomalies detected on the X-rays and the percentage of restrictive lung disease cases
Measured: 6 to 9 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 posted23 Oct 2019
- Study start1 Jan 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche en Santé, Environnement et le Travail, France, Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
- Responsible party
- Principal investigator, DENISE JOLIVOT, University Hospital, Angers
- Investigators
- Françoise Schmitt, MD, PhD, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136795
- Sponsor's protocol ID
- 49RC19_0185
- Acronym
- RestriMIS
- Status last verified
- Dec 2019
- First submitted
- 21 Oct 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chretien A, Becmeur F, Dariel A, Lamireau T, Petit T, Fouquet V, Le Mandat A, Lefebvre F, Allal H, Borgnon J, Boubnova J, Habonimana E, Panait N, Buisson P, Margaryan M, Michel JL, Gaudin J, Lardy H, Auber F, Borderon C, De Vries P, Jaby O, Fourcade L, Lecompte JF, Tolg C, Delorme B, Schmitt F, Podevin G. Thoracic skeletal anomalies following surgical treatment of esophageal atresia. Lessons from a national cohort. J Pediatr Surg. 2018 Apr;53(4):605-609. doi: 10.1016/j.jpedsurg.2017.07.013. Epub 2017 Jul 21.
PubMed 28778692Chansou MA, Sfeir R, Bonnard A, Rousseau V, Gelas T, Guinot A, Habonimana E, Micheau P, Ranke A, Talon I, Irtan S, Lamireau T, Rabattu PY, Elbaz F, Kalfa N, Panait N, Fouquet V, Lardy H, Scalabre A, Buisson P, Margaryan M, Auber F, Grosos C, Borderon C, Tolg C, Goulin J, Podevin G, Gottrand F, Schmitt F. Retrospective case-control study of nutritional and respiratory status in children with type III esophageal atresia. J Pediatr Gastroenterol Nutr. 2026 Jan;82(1):184-193. doi: 10.1002/jpn3.70238. Epub 2025 Oct 17.
PubMed 41104659
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery
- ClinicalTrials.gov ID
- NCT04136795
- Acronym / sponsor ID
- RestriMIS / 49RC19_0185
- Keywords
- esophageal atresia, thoracoscopy, rib fusion, scoliosis, Respiratory function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Institut de Recherche en Santé, Environnement et le Travail, France, Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Oct 2019 (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.
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be he occurrence of restrictive lung disease , objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
Detailed description
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.
The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
The primary endpoint will be the occurrence of restrictive lung disease, as assessed by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).
The secondary endpoints will be to measure the severity of the restrictive disease, to look for other respiratory alterations, to correlate radiological chest wall sequelae anomalies with the impact on respiratory function and to look for a causal relationship between the surgical technique used and the respiratory impact.
The methodology used will be a retrospective non interventional study on the cohort of patients included in the national esophageal atresia registry (CRACMO, Lille University Hospital) between the 1st of january 2008 and the 31st of December 2013.
All the patients included in the national esophageal atresia registry (CRACMO) having had an operation for type III esophageal atresia (long gap esophageal atresia excluded), as defined by the Ladd Classification, will be included in this study.
The exclusion criterion will be patients lost to follow up or deceased, patients having had no pulmonary function tests (PFTs) or no thoracic X-Ray during the first 6 to 9 years of follow up and patients having had thoracic surgery before the esophageal atresia repair.
The number of patients expected in the national esophageal atresia registry over the 6 years excedes 500. The number of thoracoscopy repairs should be about 50.
This study should allow us to determine if minimally invasive surgery is beneficial on mid-term respiratory function in children, related to possible post-operative chest wall sequelae.
The results obtained from this study should lead to recommendations concerning the surgical approach to esophageal atresia repair to improve the prognosis of chest wall anomalies and respiratory function in these patients. It should also help to identify patient subgroups which would benefit from a reinforced respiratory follow up. This could then lead to a hospital clinical research program (PHRC)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery | – | –Patients having had esophageal atresia (type III, long gap excluded) repair by conventional surgery (right thoracotomy) or patients having had minimally invasive surgery converted to thoracotomy between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) |
| Minimally invasive surgery | – | –Patients having had esophageal atresia (type III, long gap excluded) repair through minimally invasive surgery between the 1st of january 2008 and the 31st of December 2013 and registered on the national esophageal atresia registry (CRACMO, Lille university hospital) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients included in the national esophageal atresia registry (CRACMO) having had an operation for type III esophageal atresia, as defined by the Ladd classification between 01/01/2008 and 31/12/2013 and being followed up with thoracic X-rays and PFTs.
Key inclusion criteria (3 listed)
- Patients included in the national esophageal atresia registry (CRACMO)
- Operation for type III esophageal atresia (Ladd classification)
- Between 01/01/2008 and 31/12/2013.
Key exclusion criteria (5 listed)
- Long gap esophageal atresia
- Patients lost to follow up
- Deceased
- No PFTs or X-rays between 6 and 9 years of follow up
- Patients having had thoracic surgery before the esophageal atresia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).
Time frame: 6 to 9 years of age.
Objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines. Restrictive lung disease defined by: FEV1/FVC ratio > -1.64 Z-score and CVF < -1.64 Z-score according to ATS/ERS-GLI (American Thoracic Society \& European Respiratory Society - Global Lungs Initiative) recommendations.
6 secondary outcomes
Severity of restrictive lung disease
Time frame: 6 to 9 years of age
Assesse the occurrence of obstructive or mixed lung disease
Time frame: 6 to 9 years
Mortality rate
Time frame: Time of surgery to 6 to 9 years consultation
Percentage of post-operative complications depending on the type of surgery
Time frame: Time of surgery to 6 to 9 years consultation
Chest wall anomalies detected on thoracic X-rays
Time frame: 6 to 9 years of age
Correlation between post-operative chest wall anomalies and restrictive lung disease
Time frame: 6 to 9 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 20 Dec 2019.
- Results publication: PubMed 28778692Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chretien A, Becmeur F, Dariel A, Lamireau T, Petit T, Fouquet V, Le Mandat A, Lefebvre F, Allal H, Borgnon J, Boubnova J, Habonimana E, Panait N, Buisson P, Margaryan M, Michel JL, Gaudin J, Lardy H, Auber F, Borderon C, De Vries P, Jaby O, Fourcade L, Lecompte JF, Tolg C, Delorme B, Schmitt F, Podevin G. Thoracic skeletal anomalies following surgical treatment of esophageal atresia. Lessons from a national cohort. J Pediatr Surg. 2018 Apr;53(4):605-609. doi: 10.1016/j.jpedsurg.2017.07.013. Epub 2017 Jul 21.
- Derived from this study: PubMed 41104659Chansou MA, Sfeir R, Bonnard A, Rousseau V, Gelas T, Guinot A, Habonimana E, Micheau P, Ranke A, Talon I, Irtan S, Lamireau T, Rabattu PY, Elbaz F, Kalfa N, Panait N, Fouquet V, Lardy H, Scalabre A, Buisson P, Margaryan M, Auber F, Grosos C, Borderon C, Tolg C, Goulin J, Podevin G, Gottrand F, Schmitt F. Retrospective case-control study of nutritional and respiratory status in children with type III esophageal atresia. J Pediatr Gastroenterol Nutr. 2026 Jan;82(1):184-193. doi: 10.1002/jpn3.70238. Epub 2025 Oct 17.
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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.
Françoise Schmitt, MD, PhD principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia and Oesophageal Atresia, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 5 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 François Bastard, MD (+33 2 41 35 42 90, francois.bastard@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 occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive). (time frame: 6 to 9 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 NCT04136795, which also lists 2 linked publications.
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 20 Dec 2019.