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

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

NCT ID: NCT06252129

Condition: Lung Cancer
Lymph Node Metastasis
Pathologic Processes

Conditions: Official terms:
Lung Neoplasms
Lymphatic Metastasis
Pathologic Processes

Conditions: Keywords:
NSCLC
Lymph node dissection
Lung cancer staging

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Subjects undergoing a lung specimen lymph node dissection
Description: 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.
Arm group label: 1. Interventional group

Intervention type: Other
Intervention name: Control group
Description: Control group
Arm group label: Retrospective cohort from 2021-2020

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: February 2024

Completion date: December 2027

Lead sponsor:
Agency: Brigham and Women's Hospital
Agency class: Other

Source: Brigham and Women's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06252129