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

Phase

N/A

Condition

Lung Cancer

Non-small Cell Lung Cancer

Lung Disease

Treatment

Subjects undergoing a lung specimen lymph node dissection

Control group

Clinical Study ID

NCT06252129

DFCI IRB protocol #23-576

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
Subject without any metastasis present.
Subjects who have peripheral lung nodule location
Subjects must be 18 years of age or older.

Exclusion

Exclusion Criteria:

Subjects who received preoperative chemotherapy or radiotherapy.
Subjects who have a lung nodule located in a central location. Central tumors aredefined by those infiltrating the lobar airway.

Study Design

Subjects undergoing a lung specimen lymph node dissection

July 26, 2024

December 31, 2027

Study 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.

Connect with a study center

Brigham and Womens Hospital
Boston, Massachusetts 02115
United States
Active - Recruiting
Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115
United States
Site Not Available

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