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

NCT05453760 | Completed

• 2 other identifiers: 2022_00762022-A00655-38
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Esophageal Neoplasm

Keywords

Thoracic Esophagectomy; Esophagectomy; Postoperative pulmonary complications; lung ultrasound; critical care

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of the Lung ultrasound score

  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

  Day 1

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

  at Day 0, Day 1 and Day 3

• The presence of condensations on pleuropulmonary ultrasound in the ICU

  at Day 0, Day 1 and Day 3

• The presence of pleural effusion at D0, D1 or D3

  at Day 0, Day 1 and Day 3

• Complications according to the Dindo-Clavien classification

  at Day 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort study of esophagectomy patients in a tertiary hospital

You may qualify if:

• Thoracic Esophagectomy

You may not qualify if:

• Emphysema Death during surgery Refusal

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cédric CIRENEI, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: August 22, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)