Minimally Invasive, Diagnosis and Staging of Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Society of University Surgeons
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01011595
First received: November 9, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

The gold standard techniques to assess the extent of disease and decide on therapy for patients with lung cancer consists of cervical mediastinoscopy, which is a surgical procedure which entails an incision in the neck and the removal of lymph nodes from around the airway. Endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) are new, non-surgical techniques that have been available for the past several years and are proving invaluable in lung cancer evaluation. These techniques are minimally invasive and can be performed without surgery.

To date, there have been no head-to-head studies on the same group of patients using both the old and new techniques. The study will consist of a study which compares traditional staging techniques in lung cancer patients to new, less invasive techniques.

The significance of the proposed project is tremendous. If the new strategies prove to be equivalent (or superior) to traditional techniques, these techniques will be considered the new gold-standard tests. This will change the way lung cancer is evaluated. An equivalent or superior result will also significantly impact on patient care, cost and morbidity due to the speed, convenience and lack of operating room requirement as well as the lack of general anesthesia.


Condition Intervention
Lung Cancer
Procedure: Cervical Mediastinoscopy
Procedure: Endobronchial Ultrasound (EBUS)
Procedure: Endoscopic Ultrasound (EUS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Minimally Invasive, Trans-Luminal Diagnosis and Staging of Lung Cancer: A Prospective Head-to-Head Comparison With Traditional Gold Standard Diagnostic Techniques

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 measure will be the accuracy of the combination of minimally invasive diagnostic tests to correctly diagnose the presence or absence of mediastinal lymph node metastases compared to mediastinoscopy. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies between traditional and minimally invasive mediastinal diagnostic and staging techniques for lung cancer.


Secondary Outcome Measures:
  • The safety of all diagnostic techniques will be evaluated and compared between techniques. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
    Compare morbidity, convenience, cost and efficiencies between traditional and minimally invasive diagnostic strategies.

  • Procedure-related morbidity [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Procedural, hopsitalization and overall cost [ Time Frame: termination of enrollment ] [ Designated as safety issue: No ]
  • Clinical decision making realted to diagnostic technique results. [ Time Frame: termination of enrollment ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cervical Mediastinoscopy
    Surgical Meciastinal Lymph Node Staging
    Other Name: conventional staging procedure
    Procedure: Endobronchial Ultrasound (EBUS)
    Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy
    Other Name: Minimally invasive mediastinal staging
    Procedure: Endoscopic Ultrasound (EUS)
    Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy
    Other Name: Minimally invasive mediastinal staging
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lung lesion with mediastinal lymphadenopathy* and/or positive PET scan in the mediastinum
  • Lung lesion (>1cm) without mediastinal lymphadenopathy* or positive PET scan in the mediastinum

Exclusion Criteria:

  • Age < 18 years old
  • CT or PET positivity in an extra-thoracic site (adrenal, liver, brain, bone…)
  • Indeterminate pulmonary nodule less than 1cm in diameter without mediastinal lymphadenopathy* on CT and a negative PET scan
  • History of previous mediastinoscopy
  • Biopsy proven positive mediastinal LN(s)
  • Inability to consent for the study
  • Cervical or thoracic anatomy precluding mediastinoscopy
  • Inability to tolerate general anesthesia
  • Pre-operative plan for carinal resection or carinal pneumonectomy (CM contraindicated prior to operative procedure due to additional difficulty secondary to scarring at time of resection)
  • Active pulmonary infection (bronchitis, pneumonia)
  • Active cutaneous infection overlying proposed surgical site(s)

Lymphadenopathy will be defined as short axis LN diameter of >10 mm on CT scan

  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: NCT01011595

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de la Recherche en Santé du Québec
Society of University Surgeons
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01011595     History of Changes
Other Study ID Numbers: CE 09.107
Study First Received: November 9, 2009
Last Updated: June 20, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
lung cancer
mediastinoscopy
mediastinal lymph nodes
staging
EBUS
EUS
Endobronchial Ultrasound
Endoscopic Ultrasound

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 October 01, 2014