Clinical trial NCT04136795: Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
Official title: Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Atresia
Oesophageal Atresia
Restrictive Lung Disease
Chest Wall Anomaly
Keywords: esophageal atresia
thoracoscopy
rib fusion
scoliosis
Respiratory function
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche en Santé, Environnement et le Travail, France
name: Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
First posted: 2019-10-23
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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).
timeFrame: 6 to 9 years of age.
Secondary outcomes:
measure: Severity of restrictive lung disease
timeFrame: 6 to 9 years of age
measure: Assesse the occurrence of obstructive or mixed lung disease
timeFrame: 6 to 9 years
measure: Mortality rate
timeFrame: Time of surgery to 6 to 9 years consultation
measure: Percentage of post-operative complications depending on the type of surgery
timeFrame: Time of surgery to 6 to 9 years consultation
measure: Chest wall anomalies detected on thoracic X-rays
timeFrame: 6 to 9 years of age
measure: Correlation between post-operative chest wall anomalies and restrictive lung disease
timeFrame: 6 to 9 years of age
Other outcomes:
Locations:
city: Lille
country: France
facility: CRACMO - centre de référence des atrésies de l'oesophage
Study officials:
affiliation: University Hospital of Angers
name: Françoise Schmitt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.