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

NCT ID: NCT06252129

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2027-12-31

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.

Conditions

Lung Cancer; Lymph Node Metastasis; Pathologic Processes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1. Interventional group

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

Group Type: EXPERIMENTAL

No interventions assigned to this group

Concurrent non-interventional group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Retrospective cohort from 2021-2020

Group Type: OTHER

Control group

Intervention Type: OTHER

Control group

Interventions

Subjects 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.

Intervention Type: OTHER

Control group

Control group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paula Antonia Ugalde Figueroa

Associate Surgeon, Division of Thoracic Surgery, Principal Investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Womens Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paula Ugalde Figueroa, M.D.

Role: CONTACT

pugaldefigueroa@bwh.harvard.edu

(617) 732-7696

Facility Contacts

Paula Ugalde Figueroa THORACIC SURGEON, MD

Role: primary

pugaldefigueroa@bwh.harvard.edu

6177946491

Other Identifiers

DFCI IRB protocol #23-576

Identifier Type: -

Identifier Source: org_study_id