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

Esophageal Atresia Clinical Trial

— RestriMIS  

Official title:

Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04136795
• Other study ID #: 49RC19_0185
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: University Hospital, Angers
• Contact: François Bastard, MD
• Phone: +33 2 41 35 42 90
• Email: francois.bastard[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall Anomaly
• Congenital Abnormalities
• Esophageal Atresia
• Lung Diseases
• Oesophageal Atresia
• Restrictive Lung Disease

Locations

Country	Name	City	State
France	CRACMO - centre de référence des atrésies de l'oesophage	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Filière des Maladies Rares Abdomino-THOraciques : FIMATHO, Institut de Recherche en Santé, Environnement et le Travail, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chrétien 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of restrictive lung disease	Depending on Z-score value	6 to 9 years of age
Secondary	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	6 to 9 years
Secondary	Mortality rate	Percentage of mortality in each group, cause of death linked directly to surgery or not	Time of surgery to 6 to 9 years consultation
Secondary	Percentage of post-operative complications depending on the type of surgery	Bleeding, infection, anastomotic stenosis, anastomotic leak	Time of surgery to 6 to 9 years consultation
Secondary	Chest wall anomalies detected on thoracic X-rays	Hemivertebra, rib fusion, intercostal abnormalities, scoliosis	6 to 9 years of age
Secondary	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	6 to 9 years of age