Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound (CT0007)
Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are usually found accidentally as discrete well emarginated pulmonary lesions found within the lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic. Most solitary lung nodules are benign; however these nodules can represent early stage lung cancer. The identification of malignant pulmonary nodules is important because they represent a potential form of curable lung malignancy. Every lung nodule should therefore be investigated for the possibility of malignancy.
Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies, ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also been shown to be able to locate nodules not visualized on spiral CT.
The use of intracavitary ultrasound has been suggested by many authors as a safe and effective method for localizing hard to find nodules. It is a real time technique with no associated complications, low cost, and has the potential to save operative time. Most importantly, it may be able to prevent conversion of VATS to open operations in cases where nodules are not visualizable or locatable using VATS techniques.
The use of intracavitary US as a localization method by surgeons intra-operatively could lead to better identification of nodules. Also, this technique could avoid performing multiple procedures on patients (CT guided targeting followed by surgery) and therefore is more cost-efficient. If proven accurate, surgeon-performed intracavitary ultrasound could be used routinely during VATS procedures, increasing the chances of finding and localizing pulmonary nodules using minimally invasive techniques.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound|
- The primary outcome is to confirm the validity of surgeon-performed intra-operative intracavitary ultrasound as a localization method for difficult to visualize pulmonary nodules during VATS procedures. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Procedure: intracavitary ultrasound
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201824
|Contact: Vicky Thiffault, RN, CCRP||514-890-8000 ext email@example.com|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Monteal, Quebec, Canada, H2L 4M1|
|Contact: Vicky Thiffault, RN, CCRP 514-890-8000 ext 23432 firstname.lastname@example.org|
|Principal Investigator: Moishe Liberman, MD, PhD|
|Sub-Investigator: Mohammed Khereba, MD|
|Sub-Investigator: Pascal Ferraro, MD|
|Sub-Investigator: André Duranceau, MD|
|Sub-Investigator: Jocelyne Martin, MD|
|Principal Investigator:||Moishe Liberman, MD, PhD||Centre Hospitalier de l'Université de Montréal|