Esophageal NeoplasmOESOLUSNCT05453760
Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy
An observational study of Esophageal Neoplasm, run by University Hospital, Lille at 1 site in France.
Trial summary
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort study of esophagectomy patients in a tertiary hospital
Who may be able to join
- Thoracic Esophagectomy
Who cannot join
- Emphysema Death during surgery Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Esophageal Neoplasm
- Keywords
- Thoracic Esophagectomy, Esophagectomy, Postoperative pulmonary complications, lung ultrasound, critical care
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the Lung ultrasound score
Measured: at Day 0 (within 1 hour of tracheal extubation)
Secondary outcomes (10)
Area under the curve (AUC) of the Lung ultrasound score at Day 1
Measured: Day 1
Diaphragmatic excursion is measured via subcostal diaphragmatic ultrasound performed during the patient's clinical examination
Measured: at Day 0, Day 1 and Day 3
The presence of condensations on pleuropulmonary ultrasound in the ICU
Measured: at Day 0, Day 1 and Day 3
The presence of pleural effusion at D0, D1 or D3
Measured: at Day 0, Day 1 and Day 3
Complications according to the Dindo-Clavien classification
Measured: at Day 7
Mortality at D30 according to the LUS score at day 0 and day 1
Measured: 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.
Measured: 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.
Measured: Within 7 days post-operatively.
Evaluate whether the LUS score on day 1 correlates with PaO2/FiO2 on day 1.
Measured: A day 1.
Predictive model for postoperative pulmonary complications
Establish a predictive model integrating LUS, DUS and clinical variables (age, ASA score, surgical approach)
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start22 Aug 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric CIRENEI, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453760
- Sponsor's protocol ID
- 2022_0076
- Other IDs
- 2022-A00655-38
- Acronym
- OESOLUS
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound in the Early Detection of Postoperative Pulmonary Complications After Esophagectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05453760
- Acronym / sponsor ID
- OESOLUS / 2022_0076
- Conditions
- Esophageal Neoplasm
- Keywords
- Thoracic Esophagectomy, Esophagectomy, Postoperative pulmonary complications, lung ultrasound, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort study of esophagectomy patients in a tertiary hospital
Key inclusion criteria (1 listed)
- Thoracic Esophagectomy
Key exclusion criteria (1 listed)
- Emphysema Death during surgery Refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the curve (AUC) of the Lung ultrasound score
Time frame: at Day 0 (within 1 hour of tracheal extubation)
10 secondary outcomes
Area under the curve (AUC) of the Lung ultrasound score at Day 1
Time frame: Day 1
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
The presence of condensations on pleuropulmonary ultrasound in the ICU
Time frame: at Day 0, Day 1 and Day 3
The presence of pleural effusion at D0, D1 or D3
Time frame: at Day 0, Day 1 and Day 3
Complications according to the Dindo-Clavien classification
Time frame: at Day 7
Mortality at D30 according to the LUS score at day 0 and day 1
Time frame: 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.
Time frame: 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.
Time frame: Within 7 days post-operatively.
Evaluate whether the LUS score on day 1 correlates with PaO2/FiO2 on day 1.
Time frame: A day 1.
Predictive model for postoperative pulmonary complications
Time frame: At day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Related trials for Esophageal Neoplasm
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric CIRENEI, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasm, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of the Lung ultrasound score (time frame: at Day 0 (within 1 hour of tracheal extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.