Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy (OESOLUS)

Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study

The perioperative management of esophageal cancer has evolved considerably in recent years.

Over 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 failure, liquid pleural effusion, pneumothorax.

In general, prevention and early treatment are aimed at limiting the evolution towards acute respiratory failure requiring ventilatory assistance.

Chest radiography is essential for the presumptive diagnosis of pneumopathy in particular, but the interpretation of the images may be difficult.

Thoracic 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.

Lung 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.

Lung 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.

The main objective of the study is to determine the role of lung ultrasound (LUS) in the prediction of postoperative pulmonary complications within one hour after extubation. The secondary objectives are to determine the performance of lung and diaphragmatic ultrasound (DUS) on postoperative day 1 and to establish a predictive model integrating LUS, DUS, and clinical variables to improve early identification of patients at risk of postoperative pulmonary complications.

Study Overview

• Status: Completed
• Conditions: Esophageal Neoplasm

• Study Type: Observational
• Enrollment (Actual): 274

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort study of esophagectomy patients in a tertiary hospital

Description

Inclusion Criteria:

• Thoracic Esophagectomy

Exclusion Criteria:

• Emphysema Death during surgery Refusal

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) of the Lung ultrasound score	at Day 0 (within 1 hour of tracheal extubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of pleural effusion at D0, D1 or D3		at Day 0, Day 1 and Day 3
Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination		at Day 0, Day 1 and Day 3
Complications according to the Dindo-Clavien classification		at Day 7
The presence of condensations on pleuropulmonary ultrasound in the ICU		at Day 0, Day 1 and Day 3
Mortality at D30 according to the LUS score at day 0 and day 1		Between Day 0 et Day 30
Correlation between the LUS score on day 0 and day 1 and the mechanical energy delivered to the lung during surgery.		between the day 0 and the day 1
Assess whether diaphragmatic excursion measured on day 0, day 1, ans day 3 is predictive of CPPO within 7 days post-operatively.		Within 7 days post-operatively.
Evaluate whether the LUS score on day 1 correlates with PaO2/FiO2 on day 1.		A day 1.
Area under the curve (AUC) of the Lung ultrasound score at Day 1		Day 1
Predictive model for postoperative pulmonary complications	Establish a predictive model integrating LUS, DUS and clinical variables (age, ASA score, surgical approach)	At day 1

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Cédric CIRENEI, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: critical care; Postoperative pulmonary complications; lung ultrasound; Esophagectomy; Thoracic Esophagectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2022_0076; 2022-A00655-38 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No