Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06252129

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Paula Ugalde Figueroa THORACIC SURGEON, MD

CONTACT

[email protected]

617-794-6491

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 criteria

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

Treatment and study plan

Subjects undergoing a lung specimen lymph node dissection

Other

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.

Control Group

Other

Control group

Primary outcomes

  1. Number of lymph nodes sampled

    Time frame: 2 weeks

    To compare the number of stations and lymph nodes sampled when adopting a standardized technique compared to the conventional (prior) technique.

  2. Nodal upstage rate

    Time frame: 2 weeks

    Determine the number of cases upstaged to N1 with the intrapulmonary lymph node dissection compared to the conventional technique.

Secondary outcomes

  1. 3y RFS

    Time frame: 3 years

    Three years recurrence-free survival rate of patients undergoing standardize dissection versus conventional technique.

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Ugalde Figueroa, M.D.

CONTACT

[email protected]

(617) 732-7696

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.