Lung Cancer, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
Conditions
Keywords
Mediastinal Staging, Nodal Disease, Endobronchial Ultrasound, Diagnostic Testing
Brief summary
Before deciding on treatment for patients with lung cancer, a critical step in the investigation is finding out whether the lymph nodes in the chest contain cancer cells. This is accomplished with a biopsy of the lymph nodes through the airway wall, known as Endobronchial Ultrasound-guided Transbronchial Needle Aspiration. Guidelines require that every single lymph node in the chest be biopsied through a process called Systematic Sampling. However, emerging data suggests that the lymph nodes that appear benign on imaging and ultrasound do not need a biopsy. A proposed alternative to the inefficient Systematic Sampling is the simplified Selective Targeted Sampling of the lymph nodes, whereby only lymph nodes that look malignant are biopsied. This trial will evaluate the simplified Selective Targeted Sampling of lymph nodes and compare it to Systematic Sampling to see whether it is equally as effective in staging lung cancer.
Detailed description
Treatment decisions in Non-Small Lung Cancer (NSCLC) are reliant on a thorough staging process that includes imaging with Computed Tomography (CT), Positron Emission Tomography (PET) and Systematic Sampling (SS) of mediastinal lymph nodes (LNs) by Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA). Collectively, the results of these staging procedures dictate whether patients will be treated with surgery, radiation and/or chemotherapy. Current guidelines for SS through EBUS-TBNA mandate the biopsy of at least 3 mediastinal LN stations (4R, 4L and 7) in the chest, even if they appear normal on CT and PET scan. Despite improvements in diagnostic techniques and safety, LN biopsies remain onerous for the patient and costly to our healthcare system. SS is also unreliable, yielding inconclusive pathology results in 42.14% of cases, especially for Triple Normal LNs, which are LNs that appear normal on PET, and CT, and EBUS. In fact, SS results in mostly negative or inconclusive biopsies for Triple Normal LNs, which may be due in part to their very low probability (\< 6%) of malignancy. As such, the researchers have proposed to replace the onerous and unreliable process of SS by a simpler Selective Targeted Sampling (STS) staging process. In STS, Triple Normal LNs will not be biopsied, due to the very high negative predictive value (NPV) of malignancy. STS follows the simple notion that only LNs that have the potential to be malignant should be biopsied, whereas LNs which are very likely benign (i.e. Triple Normal LNs) should not be biopsied.
Interventions
DIAGNOSTIC_TESTSelective Targeted Sampling
Mediastinal lymph nodes are assessed with the CLNS, and only those appearing malignant with the score are biopsied. Triple Normal lymph nodes (normal appearing on PET, CT and EBUS) are not biopsied.
DIAGNOSTIC_TESTSystematic Sampling
All examined mediastinal lymph nodes are biopsied, regardless of whether they appear normal during PET, CT and EBUS.
Sponsors
Health Sciences Centre, Winnipeg, Manitoba
Royal Alexandra Hospital
Toronto General Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University Health Centre/Research Institute of the McGill University Health Centre
St. Joseph's Healthcare Hamilton
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A prospective pan-Canadian, multicentered, non-inferiority crossover study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Both CT and PET scans completed prior to EBUS * Suspected or confirmed NSCLC requiring mediastinal staging * cN0-cN1 as indicated by CT and PET scans
Exclusion criteria
* Patients with cN0 disease AND peripheral tumors AND tumor \< 2 cm in diameter, as they do not require mediastinal staging * Evidence of cN2 disease or higher on CT and PET scans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-Inferiority Margin between Selective Targeted Sampling and Systematic Sampling | 2 years | A margin of 5% or less would be considered satisfactory for STS to be deemed non-inferior to SS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement (between staging methods) | 2 years | Based on Cohen's Kappa statistics |
| Inconclusive Biopsy Rate | 2 years | Percentage of lymph nodes with inconclusive pathology from biopsy |
| Diagnostic Statistics (between staging methods) | 2 years | Sensitivity, specificity, negative predictive value and positive predictive value |
| Difference in Procedure Length | 2 years | For each sampling method (in minutes) |
| Difference in Cost per Procedure | 2 years | For each sampling method (sum of dollar costs for EBUS procedure) |
| Diagnostic Yield (accuracy) | 2 years | Proportion of lymph nodes with a pathological diagnosis for both sampling methods |
Countries
Canada
Outcome results
None listed