Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens

Mass General Brigham

Status: Enrolling

Conditions: Lymph Node Metastasis; Lung Cancer; Pathologic Processes

Treatments: Other: Subjects undergoing a lung specimen lymph node dissection; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06252129

DFCI IRB protocol #23-576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

1. Interventional group

Experimental group

Description:

subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol

Concurrent non-interventional group

No Intervention group

Retrospective cohort from 2021-2020

Other group

Treatment:

Other: Control group