Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound

NCT01201824 | Completed

• 1 other identifier: CE 10.115
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

lung cancer; intracavitary ultrasound; pulmonary nodules; VATS procedures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT.

  3-6 months

• To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy.

  6 months

Study Arms (1)

1

OTHER

Procedure: intracavitary ultrasound

Interventions

intracavitary ultrasound PROCEDURE

intracavitary ultrasound done during surgical intervention

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Monteal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Khereba M, Ferraro P, Duranceau A, Martin J, Goudie E, Thiffault V, Liberman M. Thoracoscopic localization of intraparenchymal pulmonary nodules using direct intracavitary thoracoscopic ultrasonography prevents conversion of VATS procedures to thoracotomy in selected patients. J Thorac Cardiovasc Surg. 2012 Nov;144(5):1160-5. doi: 10.1016/j.jtcvs.2012.08.034. Epub 2012 Sep 12.

  PMID: 22980667 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 15, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-05

Locations

CA (1)