NCT03625947

Efficacy and Safety of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemoptysis
• Cancer

Interventions

Type	Name	Description
OTHER	Argon Plasma Coagulation	Patients will be treated with Argon Plasma Coagulation. Argon plasma coagulation (APC) is a form of non contact electrocoagulation. APC utilizes electrically conductive argon plasma as a medium to deliver high-frequency current via a flexible probe. The argon plasma flow transfers electricity between the probe and the target tissue. Tracheobronchial access is obtained by passing the probe through the working channel of the bronchoscope. On arrival to the tissue, the application of energy causes uniform zones of desiccation, coagulation and devitalization in the areas receiving treatment, thus inducing hemostasis.

Timeline

• Start date: 2018-08-08
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2018-08-10
• Last updated: 2023-08-01

Locations

1 site across 1 country: Italy