Use of Thoracoscopic Intraoperative Lung Ultrasound to Identify Pulmonary Metastases in Patients Submitted to Pulmonary Metastasectomy With Radical Intent.

Summary

Experience drawn from many scientific articles showed that many patients who develop a limited pattern of pulmonary metastases after treatment of a primary tumor may benefit from surgical resection of the lung deposits. Pulmonary metastasectomy with curative intent is widely performed with the aim of prolonging life and, in some cases, being curative. Usually the surgical strategy is defined based on analysis of radiological investigations, performed during a follow-up program after resection of a tumor. However, many studies showed that the actual sensitivity of this examinations, namely computed tomography (CT) and positron-emission tomography (PET) is far from being 100% and finding further unexpected nodules at operation with lung manual palpation is not uncommon. Many surgeons perform pulmonary metastasectomy with a minimally invasive approach, in view of a less morbid and more cosmetic approach, but lung palpation is considerably hampered and surgical radicality might be impaired. With this study the investigators want to assess the ability of lung ultrasonography performed via a key-hole access (thoracoscopy, VATS) in detecting lung nodules compared with the standard practice represented by open thoracotomy, that is a wider incision that allows manual exploration of the organ. Therefore, every patient enrolled will undergo a double phase surgical approach: a first phase by thoracoscopy where a thorough lung ultrasonography will be performed and number and position of lung nodules will be annotated, and a second phase by open thoracotomy where lung is palpated and suspicious nodules will be removed. The incisions used for the first phase will be extended for the second, rendering any other procedure for the execution of lung ultrasonography unnecessary.

Should this study demonstrate a non-inferiority of lung ultrasonography in detecting lung nodules compared with manual palpation of the lung, patients should be offered a less invasive approach for treatment of their condition with no concerns regarding a potential lower therapeutic effect.

Conditions

• Pulmonary Metastases

Interventions

DIAGNOSTIC_TEST

Intraoperative intracavitary lung ultrasonography

Ultrasonography on the deflated lung for detection of lung nodules

Sponsors & Collaborators

• Maastricht University

  collaborator OTHER

• Azienda Sanitaria-Universitaria Integrata di Udine

  lead OTHER

Principal Investigators

• Francesco Londero, MD · Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

• Angelo Morelli, MD · Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

• Sandro Gelsomino, MD, PhD, FESC · Cardiothoracic Department Maastricht University Hospital, Maastricht, The Netherlands

• Luigi Castriotta, MD · Clinical Epidemiology Department, ASUI S Maria della Misericordia, Udine

• William Grossi, MD · Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

• Gianluca Masullo, MD · Thoracic Surgery Unit, ASUI S Maria della Misericordia, Udine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2021-12-31

Completion

2022-01-15

Countries

• Italy

Study Locations