Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT04136795
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2019-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004933', 'term': 'Esophageal Atresia'}, {'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-19', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Severity of restrictive lung disease', 'timeFrame': '6 to 9 years of age', 'description': 'Depending on Z-score value'}, {'measure': 'Assesse the occurrence of obstructive or mixed lung disease', 'timeFrame': '6 to 9 years', 'description': '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'}, {'measure': 'Mortality rate', 'timeFrame': 'Time of surgery to 6 to 9 years consultation', 'description': 'Percentage of mortality in each group, cause of death linked directly to surgery or not'}, {'measure': 'Percentage of post-operative complications depending on the type of surgery', 'timeFrame': 'Time of surgery to 6 to 9 years consultation', 'description': 'Bleeding, infection, anastomotic stenosis, anastomotic leak'}, {'measure': 'Chest wall anomalies detected on thoracic X-rays', 'timeFrame': '6 to 9 years of age', 'description': 'Hemivertebra, rib fusion, intercostal abnormalities, scoliosis'}, {'measure': 'Correlation between post-operative chest wall anomalies and restrictive lung disease', 'timeFrame': '6 to 9 years of age', 'description': 'In each group, comparison of the percentage of chest wall anomalies detected on the X-rays and the percentage of restrictive lung disease cases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal atresia', 'thoracoscopy', 'rib fusion', 'scoliosis', 'Respiratory function'], 'conditions': ['Esophageal Atresia', 'Oesophageal Atresia', 'Restrictive Lung Disease', 'Chest Wall Anomaly']}, 'referencesModule': {'references': [{'pmid': '28778692', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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).\n\nThe 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).", 'detailedDescription': "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.\n\nThe 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).\n\nThe 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).\n\nThe 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.\n\nThe 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.\n\nAll 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.\n\nThe 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.\n\nThe 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.\n\nThis 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.\n\nThe 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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in the national esophageal atresia registry (CRACMO)\n* Operation for type III esophageal atresia (Ladd classification)\n* Between 01/01/2008 and 31/12/2013.\n\nExclusion Criteria:\n\n* Long gap esophageal atresia\n* Patients lost to follow up\n* Deceased\n* No PFTs or X-rays between 6 and 9 years of follow up\n* Patients having had thoracic surgery before the esophageal atresia repair'}, 'identificationModule': {'nctId': 'NCT04136795', 'acronym': 'RestriMIS', 'briefTitle': 'Evaluation of the Respiratory Impact After Conventional or Minimally Invasive Esophageal Atresia Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery', 'orgStudyIdInfo': {'id': '49RC19_0185'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional surgery', 'description': '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)'}, {'label': 'Minimally invasive surgery', 'description': '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)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Rony Sfeir, MD', 'role': 'CONTACT', 'email': 'Rony.SFEIR@CHRU-LILLE.FR', 'phone': '+33 3 20 44 59 62'}], 'facility': "CRACMO - centre de référence des atrésies de l'oesophage", 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'François Bastard, MD', 'role': 'CONTACT', 'email': 'francois.bastard@chu-angers.fr', 'phone': '+33 2 41 35 42 90'}], 'overallOfficials': [{'name': 'Françoise Schmitt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institut de Recherche en Santé, Environnement et le Travail, France', 'class': 'OTHER'}, {'name': 'Filière des Maladies Rares Abdomino-THOraciques : FIMATHO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Françoise Schmitt', 'investigatorFullName': 'DENISE JOLIVOT', 'investigatorAffiliation': 'University Hospital, Angers'}}}}