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

Not Applicable

Not yet recruiting

• Conditions: Pathologic Processes; Lung Cancer; Lymph Node Metastasis
• Interventions: Other: Subjects undergoing a lung specimen lymph node dissection; Other: Control group

• Registration Number: NCT06252129
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Status Verified: 2024-02
• Study Start: 2024-02
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-04
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Interventional group	Subjects undergoing a lung specimen lymph node dissection	subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol
Retrospective cohort from 2021-2020	Control group	-

Primary Outcome Measures

Name	Time	Method
Nodal upstage rate	2 weeks	Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.
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.

Secondary Outcome Measures

Name	Time	Method
3y RFS	3 years	Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique.