Efficacy and Safety of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 07/28/2018 |
| Estimated Enrollment Submitted: | 08/06/2018 |
| First Posted: | 08/09/2018 |
| Last Update Submitted: | 09/23/2019 |
| Last Update Posted: | 09/24/2019 |
| Actual Study Start Date: | 08/07/2018 |
| Estimated Primary Completion Date: | 07/30/2021 |
| Estimated Study Completion Date: | 07/30/2021 |
Condition or disease
Intervention/treatment
Other: Hemoptysis patients
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Hemoptysis patients Hemoptysis patients caused by endobronchial malignancies | Other: Hemoptysis patients 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation [48 hours]
Secondary Outcome Measures
1. Incidence of adverse events [48 hours]
2. Incidence of hemoptysis recurrences [3,5 months]
3. Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up [3,5 months]
4. Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention [48 hours]
