Minimally Invasive, Diagnosis and Staging of Lung Cancer

NCT01011595 | Completed

• 1 other identifier: CE 09.107
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

lung cancer; mediastinoscopy; mediastinal lymph nodes; staging; EBUS; EUS; Endobronchial Ultrasound; Endoscopic Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3-6 months

Secondary Outcomes (4)

• The safety of all diagnostic techniques will be evaluated and compared between techniques.

  3-6 months

• Procedure-related morbidity

  3-6 months

• Procedural, hopsitalization and overall cost

  termination of enrollment

• Clinical decision making realted to diagnostic technique results.

  termination of enrollment

Interventions

Cervical Mediastinoscopy PROCEDURE

Surgical Meciastinal Lymph Node Staging

Also known as: conventional staging procedure

Endobronchial Ultrasound (EBUS) PROCEDURE

Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy

Also known as: Minimally invasive mediastinal staging

Endoscopic Ultrasound (EUS) PROCEDURE

Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy

Also known as: Minimally invasive mediastinal staging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Fonds de la Recherche en Santé du Québec: collaborator
• Society of University Surgeons: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

• Liberman M, Sampalis J, Duranceau A, Thiffault V, Hadjeres R, Ferraro P. Endosonographic mediastinal lymph node staging of lung cancer. Chest. 2014 Aug;146(2):389-397. doi: 10.1378/chest.13-2349.

  PMID: 24603902 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

CA (1)