Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery

NCT04136795 | Unknown DMC

• 1 other identifier: 49RC19_0185
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Atresia; Oesophageal Atresia; Restrictive Lung Disease; Chest Wall Anomaly

Keywords

esophageal atresia; thoracoscopy; rib fusion; scoliosis; Respiratory function

Outcome Measures

Primary Outcomes (1)

• 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.

  6 to 9 years of age.

Secondary Outcomes (6)

• Severity of restrictive lung disease

  6 to 9 years of age

• Assesse the occurrence of obstructive or mixed lung disease

  6 to 9 years

• Mortality rate

  Time of surgery to 6 to 9 years consultation

• Percentage of post-operative complications depending on the type of surgery

  Time of surgery to 6 to 9 years consultation

• Chest wall anomalies detected on thoracic X-rays

  6 to 9 years of age

Study Arms (2)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Institut de Recherche en Santé, Environnement et le Travail, France: collaborator
• Filière des Maladies Rares Abdomino-THOraciques : FIMATHO: collaborator

Study Sites (1)

CRACMO - centre de référence des atrésies de l'oesophage

Lille, 59000, France

Location

Related Publications (2)

• 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.

  PMID: 28778692 RESULT

• Chansou 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.

  PMID: 41104659 DERIVED

MeSH Terms

Conditions

Esophageal Atresia; Scoliosis; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Françoise Schmitt, MD, PhD

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Bastard, MD

CONTACT

+33 2 41 35 42 90; francois.bastard@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Françoise Schmitt

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: January 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

FR (1)