Clinical trial NCT03625947: Efficacy and Safety of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemoptysis
Cancer
Keywords: Hemoptysis
Lung cancer
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hemoptysis caused by endobronchial malignancies who need an endoscopic intervention (i.e Argon Plasma Coagulation) to stop the bleeding

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.

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

Primary outcomes:
measure: Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation
timeFrame: 48 hours
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 48 hours
measure: Incidence of hemoptysis recurrences
timeFrame: 3,5 months
measure: Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up
timeFrame: 3,5 months
measure: Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention
timeFrame: 48 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Michele Mondoni
Study officials:
affiliation: University of Milan
name: Michele Mondoni, MD
role: PRINCIPAL_INVESTIGATOR
References: