跳至主要内容
临床试验/NCT01141946
NCT01141946已完成不适用

Pleural Ultrasonography in Lung Cancer - PULC

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.

研究概览

简要总结

Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. The pre-operative evaluation and consultation in patients who are to undergo operative staging or resection for lung cancer is multidimensional and involves detailed history taking, physical examination and review of imaging studies. Two important elements of both staging and pre-operative evaluation include the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm for appropriate movement. At this point in time, the pleural space evaluation is being performed using CT scan which does not allow the acquisition of real-time cytological material from pleural effusions due to the fact that the CT scans are done in a diagnostic setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and its impact on staging and post-operative pulmonary function is unknown.

Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV. Recognizing the stage early allows for more precise prognostication of disease and can lead to precision and streamlining of treatment plans for thoracic surgeons and oncologists.

详细描述

Hypotheses:

  1. Pleural ultrasonography with evaluation, quantification and aspiration of pleural effusion allows for improved pre-operative staging and alters decision-making patterns for lung cancer patients.
  2. Pleural ultrasonography with evaluation of appropriate diaphragmatic respiratory movement can predict post-operative complications in patient undergoing lung cancer surgery.

Objectives:

The goals of this project within the program are to:

  1. Evaluate the improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
  2. Evaluate the ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lung lesion being evaluated for surgery during initial consultation with a thoracic surgeon

排除标准

  • Age < 18 years old
  • Inability to consent for the study
  • Chest wall anatomy precluding PULC
  • Inability to sit upright
  • Medications including Warfarin (Coumadin) or Clopidogrel (Plavix) in patient requiring pleural fluid aspiration
  • Active cutaneous infection overlying proposed puncture site

结局指标

主要结局

The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.

时间窗: 3 months

次要结局

  • The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.(3 months)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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