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

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.

Subjects undergoing a lung specimen lymph node dissection

Control group

Paula Ugalde Figueroa, M.D.

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.

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.

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

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

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

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

Brigham and Women's Hospital

Associate Surgeon, Division of Thoracic Surgery, Principal Investigator.

All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer

Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA

Supraclavicular lymph node ultrasound

Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure and may not be tolerated in patients with severe underlying lung disease. One exception is the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group is evaluated by palpation; however, literature suggests that palpation itself fails to capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out metastasis, we may potentially up-stage more patients using ultrasound evaluation for non-palpable nodes; and offer more appropriate management. Currently, the incidence for non-palpable SCLN metastasis has not been defined in this patient population presenting for EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.

Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.

University of Minnesota

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

EBUS TBNA lymph node specimen - a part of routine diagnostic procedure

Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)

The University Clinic of Pulmonary and Allergic Diseases Golnik

MD, specialist from pulmonary diseases

A small balloon made of latex can be attached to the tip of echo-bronchoscope which is then inflated with water or saline for better apposition of the echo-endoscope and the airway wall. This may improve ultrasound image quality and aid better visualization of the lymph nodes.

Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope

Although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. Furthermore, it is uncertain whether this leads to a better diagnostic yield. To our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with EBUS. We hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.The aim of this study is to analyse whether the use of balloon during linear EBUS 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.

The Use and Effectiveness of Balloon for Endobronchial Ultrasonography

Randomized Control Trial of the Use and Effectiveness of Balloon for Endobronchial Ultrasonography.

Diagnostic yield will be calculated separately for each group with and without the use of balloon. Diagnostic yield will be defined as a satisfactory sample with presence of lymphocytes in the aspirate on the final pathology report. In order to minimise the confounding factor in diagnostic yield based on the dimensions of the LN, we chose a single LN station (4R) and patients were sub-dvided into 3 groups based on the size of the LN.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens	NCT06252129	Lung Cancer Lymph Node Meta... Pathologic Proc...	Subjects underg... Control group	18 Years -	Brigham and Women's Hospital
Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA	NCT03087305	Lung Cancer	Supraclavicular...	20 Years - 90 Years	University of Minnesota
Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA	NCT03087305	Lung Cancer	Supraclavicular...	20 Years - 90 Years	University of Minnesota
Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients	NCT02009319	Lung Cancer		18 Years -	The University Clinic of Pulmonary and Allergic Diseases Golnik
The Use and Effectiveness of Balloon for Endobronchial Ultrasonography	NCT04735094	Lung Cancer Sta...	Endobronchial b...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Maximizing Lymph Node Dissection on Fresh and Fixed Lung Cancer Resection Specimens	NCT06252129	Lung Cancer Lymph Node Meta... Pathologic Proc...	Subjects underg... Control group	18 Years -	Brigham and Women's Hospital

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