Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-08 @ 1:59 AM
Study NCT ID:
NCT05453760
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC) of the Lung ultrasound score', 'timeFrame': 'at Day 0 (within 1 hour of tracheal extubation)'}], 'secondaryOutcomes': [{'measure': 'The presence of condensations on pleuropulmonary ultrasound in the ICU', 'timeFrame': 'at Day 1 and Day 3'}, {'measure': 'The presence of pleural effusion at D0, D1 or D3', 'timeFrame': 'at Day 0, Day 1 and Day 3'}, {'measure': "Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination", 'timeFrame': 'at Day 0, Day 1 and Day 3'}, {'measure': 'Complications according to the Dindo-Clavien classification', 'timeFrame': 'at Day 7'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic Esophagectomy', 'Esophagectomy', 'Postoperative pulmonary complications', 'lung ultrasound', 'critical care'], 'conditions': ['Esophageal Neoplasm']}, 'descriptionModule': {'briefSummary': 'The perioperative management of esophageal cancer has evolved considerably in recent years.\n\nOver the last 30 years, postoperative mortality has been steadily decreasing. However, respiratory morbidity remains high (30-40%). This is due to the procedure itself requiring a thoracic approach and intraoperative unipulmonary ventilation. The postoperative pulmonary complications (PPCs) are multiple: bronchial congestion, atelectasis, pneumopathy, acute respiratory distress syndrome (ARDS), liquid pleural effusion, pneumothorax.\n\nIn general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.\n\nChest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.\n\nThoracic computed tomography (CT) is the gold standard because it is sensitive and can discriminate among differential diagnoses. This is difficult to perform: it requires intra-hospital transport of patient, who is often in acute respiratory failure, and the availability of an examination area.\n\nLung ultrasound is used at the bedside for diagnosis of lung infection in intensive care unit. This has a sensitivity close to thoracic CT and has the advantage of being feasible at any time, does not require transport of the patient and is not irradiating.\n\nLung ultrasound allows early detection of the need for ventilatory support in postoperative major abdominal surgery . In addition, the sensitivity of lung ultrasound is close to that of CT, allowing this examination to be relied upon.\n\nThe main objective of the study is to determine the role of lung ultrasound in the prediction of postoperative pulmonary complications within one hour after extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective cohort study of esophagectomy patients in a tertiary hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thoracic Esophagectomy\n\nExclusion Criteria:\n\n* Emphysema Death during surgery Refusal'}, 'identificationModule': {'nctId': 'NCT05453760', 'acronym': 'OESOLUS', 'briefTitle': 'Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '2022_0076'}, 'secondaryIdInfos': [{'id': '2022-A00655-38', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Cédric CIRENEI, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}