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

U

University of Milan

Status

Terminated

Conditions

Hemoptysis
Cancer

Treatments

Other: Argon Plasma Coagulation

Study type

Observational

Funder types

Other

Identifiers

NCT03625947
Argon

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Hemoptysis patients
Description:
Hemoptysis patients caused by endobronchial malignancies
Treatment:
Other: Argon Plasma Coagulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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