Routine Systematic Sampling vs. Targeted Sampling of Mediastinal Lymph Nodes Prior to Lung Cancer Treatment: A Feasibility Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Procedure Length
Study Overview
Brief Summary
For patients diagnosed with early stage Non-Small Cell Lung Cancer (NSCLC) on preoperative computerized tomography (CT) and positron emission tomography (PET) scans, surgical resection is usually the preferred method of treatment. However, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. To evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (EBUS) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. Unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. Currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another EBUS, or through more invasive procedures. Repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. To circumvent this issue, the investigators have developed, validated and published a 4-point score, the Canada Lymph Node Score (CLNS), which uses four features observed during EBUS to predict whether the cancer has spread to the lymph nodes or not. Research has demonstrated that lymph nodes which appear benign on both CT and PET scan that also have a CLNS of ≤1/4 are almost certainly benign. As such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy).
The investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. Systematic Sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. Targeted Sampling).To prove this hypothesis, a randomized controlled trial comparing Systematic Sampling to Targeted Sampling is required. A feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
Trial participants will remain blinded to their randomized treatment. Additionally, the biostatistician performing the analysis will be blinded as to which intervention arm participants were allocated to, as the group allocations will be coded as Group A and Group B. Provided this is an endoscopic trial, endoscopist blinding will not be feasible. Nonetheless, all patients deemed surgical candidates after EBUS will have their pathology compared to EBUS staging in order to ensure appropriate diagnosis. Pathologists performing such pathology report will be blinded to which intervention arm participants are allocated to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Referred to have EBUS for staging of confirmed or suspected NSCLC
- •Completed both a CT and PET scans
- •cN0-cN1 disease indicated on CT and PET scans
Exclusion Criteria
- •Patients with cN0 disease, peripheral tumours and tumours < 2 cm in diameter (they do not require staging)
- •Evidence of cN2 disease or higher on CT and PET scan
Arms & Interventions
Systematic Sampling
Patients will undergo systematic sampling of lymph node stations in the mediastinum with a minimum sampling of 3 stations: 4R, 4L and 7, as is the standard of care. Other stations may be included at the endoscopist's discretion. CLNS is not used for this arm.
Intervention: Systematic Sampling (Diagnostic Test)
Selective Targeted Sampling
Patients will first undergo endosonographic assessment of 3 mediastinal lymph node stations (i.e. 4R, 4L, and 7) using the four criteria of the CLNS. Lymph node stations that exhibit a CLNS >1/4 will be biopsied as is standard of care. Lymph node stations with CLNS ≤ 1/4 will be marked as "not requiring biopsy" but will be biopsied nevertheless, so that there is no deviation from the standard of care. Other stations may be included at the endoscopist's discretion.
Intervention: Selective Targeted Sampling (Diagnostic Test)
Outcomes
Primary Outcomes
Procedure Length
Time Frame: 1 Day
Calculated in minutes. Recorded for both treatment arms.
Diagnostic Accuracy
Time Frame: 1 Year
The proportion of patients in whom the treatment (CLNS or biopsy) yielded the same diagnosis as the pathology report out of the total number of patients that have received the treatment. Recorded for both treatment arms.
Recruitment Rate
Time Frame: 1 Year
Minimum acceptable recruitment rate is 70%
Secondary Outcomes
- Adverse Events(1 Year)
- Frequency of Biopsies(1 Year)
- Accrual Period(1 Year)
- Percent of Inconclusive Biopsies(1 Year)
- Prevalence of Each Possible CLNS(1 Year)
Investigators
Wael Hanna
Head of Endoscopy Services, Thoracic Surgeon
St. Joseph's Healthcare Hamilton