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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03625947
• Other study ID #: Argon
• Status: Terminated
• Start date: August 8, 2018
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2023
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Hemoptysis

Intervention

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.

Locations

Country	Name	City	State
Italy	Michele Mondoni	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation	Percentage of patients with bleeding cessation without recurrence at 48 hours after bronchoscopic Argon Plasma Coagulation employed to stop hemoptysis caused by endobronchial malignancies	48 hours
Secondary	Incidence of adverse events	Incidence of adverse events following bronchoscopic Argon Plasma Coagulation in the treatment of patients with hemoptysis and endobronchial malignancies	48 hours
Secondary	Incidence of hemoptysis recurrences	Incidence of hemoptysis recurrences (number of relapses)	3,5 months
Secondary	Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up	Number of patients with hemoptysis and endobronchial malignancies who are still alive after 3,5 months after the endoscopic intervention	3,5 months
Secondary	Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention	Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention (i.e. age, gender, ethnicity, smoking history, cancer type and stage, ECOG performance Status, concomitant heart, lung, kidney and liver disease, antiplatelet/anticoagulant therapy, creatinine and hemoglobin level and platelet count, PT and PTT values; endoscopic location of malignancy (i.e. lobe and side), endoscopic growth pattern of malignancy (i.e. exophytic, submucosal/peribronchial growth), current/former chemotherapy and radiation therapy on the chest, time from malignancy diagnosis to hemoptysis onset, time from hemoptysis onset to endoscopic treatment, necessity of blood transfusion).	48 hours