Prospective, Observational Study on the Efficacy, the Safety and the Predictors of Success of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation
研究概览
简要总结
The aim of this study is to evaluate the efficacy, the safety and the main predictors of success of bronchoscopic Argon Plasma Coagulation in patients with hemoptysis caused by endobronchial malignancies.
详细描述
Hemoptysis is a challenging symptom which may be frequently related to endobronchial malignancies. Patients with central neoplasms and hemoptysis show a lower median survival than patients with no bleeding and endobronchial neoplasms and/or patients with hemoptysis and peripheral malignant lesions.
Hemoptysis control without recurrence at 48 hours after bronchoscopic interventions may improve survival in patients with mild bleeding and endobronchial malignancies.
Argon Plasma Coagulation is considered one of the most effective techniques for endobronchial management of hemoptysis in this subset of patients. Nevertheless, few data are available in literature on its efficacy and safety, and the main predictors of success are still unclear.
In this prospective, observational study, investigators aim to evaluate the efficacy (i.e. immediate bleeding cessation without recurrence during the following 48 hours) of endoscopic Argon Plasma Coagulation in patients with hemoptysis caused by endobronchial neoplasms.
Investigators will also evaluate the safety of the procedure, the main variables associated to a successful intervention, the presence of hemoptysis relapses and patients overall survival to 3,5 months after the bronchoscopic intervention.
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
- 否
入选标准
- •Adult patients with hemoptysis caused by endobronchial (i.e. identifiable with flexible bronchoscopy) malignancies, without coagulopathy or other medically correctable causes of bleeding, who need endoscopic intervention with Argon Plasma Coagulation to stop bleeding
- •Adult patients who are able to tolerate bronchoscopy
- •Adult patients who are able to sign the written informed consent for the study participation
排除标准
- •Patients with hemoptysis caused by endobronchial malignancies with coagulopathy or other medically correctable causes of bleeding.
- •Patients who are not able to tolerate bronchoscopy
- •Patients with hemoptysis without identifiable endobronchial malignancies during flexible bronchoscopy
- •Patients with Pace-Maker and/or Automated Implantable Cardioverter- Defibrillator(AICD)
- •Patients who refuse/are not able to sign the informed consent for the study participation
结局指标
主要结局
Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation
时间窗: 48 hours
Percentage of patients with bleeding cessation without recurrence at 48 hours after bronchoscopic Argon Plasma Coagulation employed to stop hemoptysis caused by endobronchial malignancies
次要结局
- Incidence of adverse events(48 hours)
- Incidence of hemoptysis recurrences(3,5 months)
- Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up(3,5 months)
- Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention(48 hours)
研究者
Michele Mondoni
Principal investigator
University of Milan