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

NCT06252129 | Recruiting DMC

• 1 other identifier: DFCI IRB protocol #23-576
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymph Node Metastasis; Pathologic Processes; Lung Cancer

Keywords

NSCLC; Lymph node dissection; Lung cancer staging

Outcome Measures

Primary Outcomes (2)

• Number of lymph nodes sampled

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

  2 weeks

• Nodal upstage rate

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

  2 weeks

Secondary Outcomes (1)

• 3y RFS

  3 years

Study Arms (3)

1. Interventional group

EXPERIMENTAL

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

Other: Subjects undergoing a lung specimen lymph node dissection

Concurrent non-interventional group

NO INTERVENTION

Retrospective cohort from 2021-2020

OTHER

Other: Control group

Interventions

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.

1. Interventional group

Control group OTHER

Control group

Retrospective cohort from 2021-2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Lymphatic Metastasis; Pathologic Processes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Paula Ugalde Figueroa, M.D.

CONTACT

(617) 732-7696; pugaldefigueroa@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon, Division of Thoracic Surgery, Principal Investigator.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 9, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)