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

NCT ID: NCT03625947

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2023-07-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hemoptysis patients

Hemoptysis patients caused by endobronchial malignancies

Argon Plasma Coagulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

APC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Michele Mondoni

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Mondoni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

Michele Mondoni

Milan, , Italy

Countries

Italy

Other Identifiers

Argon

Identifier Type: -

Identifier Source: org_study_id