Skip to main content
OpenTrials
Completed

NCT Number: NCT05453760

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Neoplasm Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Thoracic Esophagectomy

Exclusion criteria

  • Emphysema Death during surgery Refusal

Treatment and study plan

Primary outcomes

  1. Area under the curve (AUC) of the Lung ultrasound score

    Time frame: at Day 0 (within 1 hour of tracheal extubation)

Secondary outcomes

  1. Area under the curve (AUC) of the Lung ultrasound score at Day 1

    Time frame: Day 1

  2. Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination

    Time frame: at Day 0, Day 1 and Day 3

  3. The presence of condensations on pleuropulmonary ultrasound in the ICU

    Time frame: at Day 0, Day 1 and Day 3

  4. The presence of pleural effusion at D0, D1 or D3

    Time frame: at Day 0, Day 1 and Day 3

  5. Complications according to the Dindo-Clavien classification

    Time frame: at Day 7

  6. Mortality at D30 according to the LUS score at day 0 and day 1

    Time frame: Between Day 0 et Day 30

  7. Correlation between the LUS score on day 0 and day 1 and the mechanical energy delivered to the lung during surgery.

    Time frame: between the day 0 and the day 1

  8. Assess whether diaphragmatic excursion measured on day 0, day 1, ans day 3 is predictive of CPPO within 7 days post-operatively.

    Time frame: Within 7 days post-operatively.

  9. Evaluate whether the LUS score on day 1 correlates with PaO2/FiO2 on day 1.

    Time frame: A day 1.

  10. Predictive model for postoperative pulmonary complications

    Time frame: At day 1

    Establish a predictive model integrating LUS, DUS and clinical variables (age, ASA score, surgical approach)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: OESOLUS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.