Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer

Detailed Description
-----------------
In the first phase of the study a respiratory physician was trained to perform neck ultrasound and needle sampling of enlarged cervical lymph nodes according to preset criteria. In the second phase patients with suspected lung cancer and enlarged mediastinal lymph nodes underwent routine neck ultrasound and enlarged cervical lymph nodes were sampled using fine needle and or core needle biopsy. The outcomes of interest in the study were the rate of malignant cervical lymphadenopathy defined as pathological evidence of cancer in neck lymph node samples consistent with a lung primary, adequacy of needle sampling, patient reported experience assessed by a visual analogue of discomfort associated with needle neck sampling and EBUS, and the proportion of patients that had nodal upstaging

Official Title
-----------------
Routine Neck Ultrasound by Respiratory Physicians in the Diagnosis and Staging of Patients With Lung Cancer and Mediastinal Lymphadenopathy, a Prospective Pilot Study

Conditions
-----------------
Lung Cancer Metastatic, Nodes, Lung

Intervention / Treatment
-----------------
* Diagnostic Test: Neck ultrasound guide lymph node sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected and later on confirmed lung cancer Presence of at least one mediastinal lymph node measuring > 10 mm in short diameter on computerised Tomography Exclusion Criteria: Age <18 History any malignancy apart from non-melanomatous skin cancer Inability to give informed consent

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected lung cancer<br>Suspected and later on confirmed lung cancer with evidence of mediastinal lymphadenopathy on computerised tomography | Diagnostic Test: Neck ultrasound guide lymph node sampling<br>* Neck ultrasound done first and lymph nodes larger than 5 mm that are technically feasible are sampled using fine needle aspiration and/or core needle biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of lymph node sampling | Presence of lymphocytes or malignant cells in biopsy samples | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with malignant cervical lymphadenopathy | Presence of malignant cells consistent with lung cancer in cervical lymph node samples | 7 days | 
| Proportion of patients with nodal status upstaged | Defined as a change from cN2 to cN3 according to the 8th edition of the Tumour Node Metastasis TNM staging system | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, lymphadenopathy, lung cancer