Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound

Lung Cancer Clinical Trial

— CT0007  

Official title:

Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201824
• Other study ID #: CE 10.115
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: November 24, 2015
• Start date: September 2010
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection.

Exclusion Criteria:

• Inability to consent for the study.

• Patients less than 18 years old.

• Patients with pulmonary nodules easily located during VATS.

• Patients with tumours extending to visceral pleura or chest wall.

• Patients who have chest anatomy precluding VATS resection.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Intervention

Procedure:
• intracavitary ultrasound
intracavitary ultrasound done during surgical intervention

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Monteal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3-6 months	No
Secondary	To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT.		3-6 months	No
Secondary	To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy.		6 months	No