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临床试验/NCT03903315
NCT03903315已完成不适用

Central Malignant Airway Obstructions: Medical Treatment Alone Versus Endoscopic and Medical Treatment. A Multicentric Retrospective Study

University of Modena and Reggio Emilia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月1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
100
试验地点
1
主要终点
1 year Survival

研究概览

简要总结

The obstruction of the central airways (CAO) may be caused by a large variety of malignant and non malignant processes, and it may present with a variety of symptoms ranging from mild shortness of breath to life-threatening respiratory failure.

The epidemiologic impact of lung cancer leads to an increasing number of patients developing complications of proximal endobronchial disease. An estimated 20-30% of patients with lung cancer will develop complications associated with airway obstruction, e.g. dyspnea, pneumonia and atelectasis, and up to 40% of lung cancer deaths may be attributed to locoregional disease.

Although lung cancer patients with CAO are not candidates for surgical resection, more than 80% of these patients can receive palliative treatment using interventional bronchoscopy; in addiction, almost the 85% of these procedures reach luminal clearance and endoscopic success in terms of symptomatic relief, of pulmonary function and quality of life.

There are no definitive data about factors such as type of disease or site of the lesion which may affect the use of a single or a combined endoscopic modality or stenting in the treatment of airway obstructions. A Dalar's retrospective study showed that airway stenting is a useful treatment modality besides the other interventional bronchoscopic procedures: it not only provides rapid relief of symptoms and an improved quality of life, but also gives additional time for adjuvant chemo-radiotherapy that might provide prolonged survival.

Since Dumon introduced the first dedicated endoluminal airway stent, there was a clear immediate relief of respiratory symptoms and significant quality survival in most patients (9). In a Miyazawa's study all patients with malignant central airway obstruction had significant improvements in dyspnea and also in spirometry after stenting, and the author suggested that the correct positioning of the stent at the choke point leads to maximal symptomatic benefit in these patients. The choice of different airway stents can be made based on the nature (intrinsic, extrinsic or combined) and site of the lesion: for example the Dumon stent can be preferred in lesions of trachea and right main bronchus, the Ultraflex stent on the left and stenosis beyond the main bronchi. The underlying disease, the site of lesion and treatment modality are known as independent predictors of survival. Complications related to the placement of stents include re-obstructions of the lumen by tumor, granuloma formation at the stent side, mucous plugging and migration of the stent; with the use of laser, both perforation of airway wall and fire.

Regarding laser resection for malignant airway obstruction, it is associated with improved survival rates (60% of patients alive at 7 months in one study). As these studies were not randomized trials, it is impossible to conclude that the laser therapy was responsible for the improved survival, but it is likely that laser therapy provided a rapid and safe means of relieving central airway obstruction, which is associated with a high mortality rate.

The strategy and modality of treatment for malignant central airway obstructions depends not only on the endoscopic characteristics and location of the lesions, but also on the patient's comorbidities, pulmonary function, previous treatment and life expectancy. The primary purpose of treatment with interventional bronchoscopy alone remains to improve symptom control and quality of life, not to improve the prognosis. However, the advent of molecular-targeted therapy may change the impact of interventional bronchoscopy, especially in lung cancer patients with EGFR mutations: in a Tomoyuki case report there is the first description of the use of endoscopic treatment plus molecular-targeted therapy as combination treatment, with benefits in terms of patient's general conditions and quality of life. Moreover, some researchers have reported cases of malignant lymphoma patients with central airway obstruction who were successfully treated using interventional bronchoscopy followed by systemic chemotherapy.

The aim of this study is to evaluate the differences between patients with central malignant airway obstruction treated only with medical therapy versus patients submitted to endoscopic plus medical therapy in terms of prognosis, quality of life and access to health services.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with malignant central airways obstruction admitted to the Bronchoscopy Unit of the University Hospital of Modena (Italy) and to the Bronchoscopy Unit of the Arcispedale Santa Maria Nuova of Reggio Emilia (Italy)

排除标准

  • metastatic disease
  • small cell lung cancer
  • pregnancy
  • low performance status at the time of diagnosis

结局指标

主要结局

1 year Survival

时间窗: Ten years

Assessment of survival through medical records and reports consultation

次要结局

  • Atelectasis(Ten years)
  • Infections(Ten years)
  • Respiratory failure(Ten years)
  • Hospital admission(Ten years)
  • Need for palliative care(Ten years)

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Marchioni

Principal Investigator

University of Modena and Reggio Emilia

研究点 (1)

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