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临床试验/NCT02599883
NCT02599883已完成不适用

Impact of Low-dose Computed Tomography on the Management of Chronic Obstructive Pulmonary Disease Patients: an Evidence-based Study

Azienda Ospedaliero-Universitaria di Parma0 个研究点目标入组 195 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
主要终点
Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)

研究概览

简要总结

Background: Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of chronic morbidity and mortality worldwide. There is debate about diagnosis and management of COPD because it was described as complex syndrome accounting for various pulmonary and extrapulmonary abnormalities. As a result, there is consensus that both clinical evaluation and pulmonary function tests (PFTs) data by themselves do not adequately describe the complexity of the disease. The chest radiograph is the sole imaging examination recommended for the routine evaluation of these patients by the physicians guidelines (GOLD guidelines),which, however, are also debating on the utility of computed tomography (CT) in this setting. Indeed, a number of studies reported a dramatic increasing use of CT of the chest for COPD assessment, in both clinical and research settings. COPD assessment by CT seems to improve the accuracy and completeness of the clinical evaluation of these patients. Nevertheless, the clinical utility of CT has yet to be proved by prospective studies or defined by guidelines.

Objectives: To evaluate the change in the diagnosis and management of COPD when multiple CT-derived information is added to pre-test evaluation.

Methods: Four pulmonologists with various expertise in the field will review clinical data, PFTs results, and chest radiographs of 200 consecutive COPD patients diagnosed according to current guidelines. Therefore, after two months from the first evaluation, the pulmonologists will review the clinical and PFTs records with comprehensive information about low-dose CT (LDCT) previously performed in a week from the chest radiograph. Information about LDCT findings will include qualitative assessment by an experienced chest radiologist and quantitative analysis by means of an innovative 3D imaging dedicated software. Phenotype assessment and patient care decisions (e.g. therapeutic and follow-up strategies, need of additional tests etc.) will be recorded before and after assimilation of LDCT data.

Expected results: This evidence-based prospective study will test the impact of chest LDCT on management of COPD patient. In addition, the level of agreement between pulmonologists in terms of diagnosis and therapeutic strategies will be assessed. Furthermore, the study will evaluate the need for additional tests referable to LDCT information and their impact on the health care system (e.g. in terms of additional costs).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD diagnosis according to ATS/ERS criteria (post-bronchodilator FEV1 to FVC ratio < 0.7);
  • clinical stability, namely no acute exacerbation in the previous 4 weeks;
  • clinical indication for low-dose computed tomography (LDCT) to investigate bronchiectasis, interstitial lung disease, or pulmonary hypertension.

排除标准

  • pregnancy;
  • patients with congenital or acquired immune deficit;
  • patients with lung transplantation;
  • patients under oxygen therapy;
  • patients with diagnosis of asthma or other clinically relevant pulmonary disease other than COPD.

结局指标

主要结局

Impact of diagnostic imaging in assessing COPD by qualitative and quantitative evaluation (questionnaire)

时间窗: Up to 3 years

To quantify the refinement of the diagnosis of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.

Clinical management of COPD in relation to therapy adjustment (questionnaire)

时间窗: Up to 3 years

To describe the change in management of COPD patients when LDCT data are added to standard evaluation, namely, conventional clinical-functional assessment and chest radiography.

次要结局

  • Intra-observer agreement before and after disclosure of LDCT features (questionnaire)(Up to 3 years)
  • Inter-observer agreement (questionnaire)(Up to 3 years)
  • Additional costs derived from change in management of COPD after disclosure of LDCT features (comparison of costs)(Up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Sverzellati

Professor, MD, PhD

Azienda Ospedaliero-Universitaria di Parma

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