Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound (CT0007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01201824
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: intracavitary ultrasound Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound
Study Start Date : September 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
1 Procedure: intracavitary ultrasound
intracavitary ultrasound done during surgical intervention

Primary Outcome Measures :
  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. [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT. [ Time Frame: 3-6 months ]
  2. To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01201824

Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Monteal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator: Moishe Liberman, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM) Identifier: NCT01201824     History of Changes
Other Study ID Numbers: CE 10.115
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: May 2015

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
lung cancer
intracavitary ultrasound
pulmonary nodules
VATS procedures

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases