Lung Cancer, Lymph Node Metastasis, Pathologic Processes
Conditions
Keywords
NSCLC, Lymph node dissection, Lung cancer staging
Brief summary
Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
Detailed description
Anatomic lung resection with systematic mediastinal lymph node dissection is the standard of care for patients with clinical stage I or II non-small cell lung cancer (NSCLC). While the best type of resection may sometimes be debated, it is clear that mediastinal, hilar, and lobar lymph nodes (LNs) should be routinely retrieved to achieve a complete lung cancer resection. According to major international guidelines, at least 3 hilar/intrapulmonary stations and 3 mediastinal stations should be assessed during resection. Although there is still a debate over whether the ideal number of LN stations sampled or the total number of LNs removed per station provides a better analysis, radical systematic LN dissection seems to offer the best oncological outcomes. In fact, in patients with tumors ≤4 cm in diameter completely resected, the quality of the mediastinal lymph node dissection and the thoroughness of the examination of the surgical specimen will select candidates for adjuvant treatment and define oncologic prognosis. The consequences of an incorrect lymph node classification can be substantial: while patients with N0 NSCLC have approximately 75% 5-year overall survival (OS), patients with NSCLC classified as N1 have a 5-year OS of 49%, and patients with NSCLC classified as N2 a 5-year OS of 36%. Therefore, the burden of determining the correct prognosis lies on the surgeon to perform a rigorous and thorough oncological resection, and on the pathologist to fully assess enough intrapulmonary LNs. Inaccuracy by either specialist leads to pathologic understage and suboptimal clinical management, which will lead to poor patient outcomes. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.
Interventions
OTHERSubjects undergoing a lung specimen lymph node dissection
A lobectomy specimen's resection will undergo systematic lymph node dissection either by the patient's treating thoracic surgeon and/or by a member of the pathology team. The protocol for a standardized lymph node dissection consists of a series of blunt peribronchial dissections starting from the hilum to the periphery, with particular attention to points of airway bifurcation where intrapulmonary lymph nodes aggregate. By emphasizing the intrapulmonary lymph node map and a standardized dissection, the team will remove more lymph nodes from the lobectomy specimen, resulting in an accurate N staging.
OTHERControl group
Control group
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects with a lung nodule or mass who are eligible to undergo a lobectomy. 2. Subject without any metastasis present. 3. Subjects who have peripheral lung nodule location 4. Subjects must be 18 years of age or older.
Exclusion criteria
1. Subjects who received preoperative chemotherapy or radiotherapy. 2. Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lymph nodes sampled | 2 weeks | To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique. |
| Nodal upstage rate | 2 weeks | Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3y RFS | 3 years | Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique. |
Countries
United States
Contacts
CONTACTPaula Ugalde Figueroa, M.D.
Outcome results
None listed