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临床试验/NCT03970564
NCT03970564已完成不适用

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

University College Hospital Galway1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Adequacy of lymph node sampling

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

接受健康志愿者
否

入选标准

  • •Suspected and later on confirmed lung cancer
  • •Presence of at least one mediastinal lymph node measuring > 10 mm in short diameter on computerised Tomography

排除标准

  • •History any malignancy apart from non-melanomatous skin cancer
  • •Inability to give informed consent

结局指标

主要结局

Adequacy of lymph node sampling

时间窗: 7 days

Presence of lymphocytes or malignant cells in biopsy samples

次要结局

  • Proportion of patients with nodal status upstaged(7 days)
  • Proportion of patients with malignant cervical lymphadenopathy(7 days)

研究者

发起方
University College Hospital Galway
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Ahmed

Clinical fellow

University College Hospital Galway

研究点 (1)

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