Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound (CT0007)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intracavitary ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring lung cancer, intracavitary ultrasound, pulmonary nodules, VATS procedures
Eligibility Criteria
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.
Sites / Locations
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT.
To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy.
Full Information
NCT ID
NCT01201824
First Posted
September 13, 2010
Last Updated
November 24, 2015
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT01201824
Brief Title
Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound
Acronym
CT0007
Official Title
Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, intracavitary ultrasound, pulmonary nodules, VATS procedures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
intracavitary ultrasound
Intervention Description
intracavitary ultrasound done during surgical intervention
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the ability of intra-operative intracavitary ultrasound to detect new pulmonary nodules, not detected by CT.
Time Frame
3-6 months
Title
To assess the ability of VATS-US to decrease conversion rates of VATS procedures to open thoracotomy.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moishe Liberman, MD, PhD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Monteal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22980667
Citation
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.
Results Reference
derived
Learn more about this trial
Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound
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