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

Terminated

• Conditions: Cancer; Hemoptysis
• Interventions: Other: Argon Plasma Coagulation

• Registration Number: NCT03625947
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study First Submitted: 2018-07-29
• Study First Submitted QC: 2018-08-07
• Study Start: 2018-08-08
• Study First Posted: 2018-08-10
• Status Verified: 2023-07
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemoptysis patients	Argon Plasma Coagulation	Hemoptysis patients caused by endobronchial malignancies

Primary Outcome Measures

Name	Time	Method
Percentage of patients with bleeding cessation without recurrence at 48 after bronchoscopic Argon Plasma Coagulation	48 hours	Percentage of patients with bleeding cessation without recurrence at 48 hours after bronchoscopic Argon Plasma Coagulation employed to stop hemoptysis caused by endobronchial malignancies

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	48 hours	Incidence of adverse events following bronchoscopic Argon Plasma Coagulation in the treatment of patients with hemoptysis and endobronchial malignancies
Incidence of hemoptysis recurrences	3,5 months	Incidence of hemoptysis recurrences (number of relapses)
Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up	3,5 months	Number of patients with hemoptysis and endobronchial malignancies who are still alive after 3,5 months after the endoscopic intervention
Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention	48 hours	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).

Trial Locations

Locations (1)

Michele Mondoni; 🇮🇹 Milan, Italy