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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01201824
First received: September 13, 2010
Last updated: November 4, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

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. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: intracavitary ultrasound
    intracavitary ultrasound done during surgical intervention
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201824

Contacts
Contact: Vicky Thiffault, RN, CCRP 514-890-8000 ext 23432 vicky.thiffault.chum@ssss.gouv.qc.ca

Locations
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         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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: November 4, 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
Multiple Pulmonary Nodules
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014