Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer

Lung Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970564
• Other study ID #: Version 01
• Status: Completed
• Start date: October 21, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2019
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study of routine neck ultrasound performed by respiratory physicians in patients with mediastinal lymphadenopathy and suspected lung cancer

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2018
• Est. primary completion date: May 21, 2018
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms
• Lymphadenopathy
• Nodes, Lung

Intervention

Diagnostic Test:
• Neck 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

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway

Sponsors (2)

Lead Sponsor	Collaborator
University College Hospital Galway	European Respiratory Society

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of lymph node sampling	Presence of lymphocytes or malignant cells in biopsy samples	7 days
Secondary	Proportion of patients with malignant cervical lymphadenopathy	Presence of malignant cells consistent with lung cancer in cervical lymph node samples	7 days
Secondary	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