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Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03970564
Enrollment
30
Registered
2019-05-31
Start date
2016-10-21
Completion date
2018-05-30
Last updated
2019-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Metastatic, Nodes, Lung

Keywords

ultrasound, lymphadenopathy, lung cancer

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

Interventions

DIAGNOSTIC_TESTNeck ultrasound guide lymph node sampling

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

Sponsors

European Respiratory Society
CollaboratorOTHER
University College Hospital Galway
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
Adequacy of lymph node sampling7 daysPresence of lymphocytes or malignant cells in biopsy samples

Secondary

MeasureTime frameDescription
Proportion of patients with malignant cervical lymphadenopathy7 daysPresence of malignant cells consistent with lung cancer in cervical lymph node samples
Proportion of patients with nodal status upstaged7 daysDefined as a change from cN2 to cN3 according to the 8th edition of the Tumour Node Metastasis TNM staging system

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026