Health TrialsbyHealthPanel

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

ConditionsLung CancerLymph Node MetastasisPathologic Processes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subjects undergoing a lung specimen lymph node dissection

    Other intervention

    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 intervention

    Control group

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: 1. Interventional groupExperimental treatment 1 intervention
Group B: Concurrent non-interventional groupNo intervention 0 interventions
Group C: Retrospective cohort from 2021-2020Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 weeks
2

Nodal upstage rate

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

Time frame
2 weeks

Secondary outcomes

1

3y RFS

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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