Thoracoscopic Localization of Pulmonary Nodules Using Direct Intracavitary Thoracoscopic Ultrasound (CT0007)
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Purpose
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 | Intervention |
|---|---|
|
Lung Cancer |
Procedure: intracavitary ultrasound |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
-
Procedure: intracavitary ultrasound
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Vicky Thiffault, RN, CCRP | 514-890-8000 ext 23432 | vicky.thiffault.chum@ssss.gouv.qc.ca |
| Canada, Quebec | |
| Centre Hospitalier de l'Université de Montréal | Recruiting |
| Monteal, Quebec, Canada, H2L 4M1 | |
| Contact: Vicky Thiffault, RN, CCRP 514-890-8000 ext 23432 vicky.thiffault.chum@ssss.gouv.qc.ca | |
| 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 |
More Information
No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01201824 History of Changes |
| Other Study ID Numbers: | CE 10.115 |
| Study First Received: | September 13, 2010 |
| Last Updated: | April 30, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
lung cancer intracavitary ultrasound pulmonary nodules VATS procedures |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013