An observational study in Hemoptysis and Cancer, sponsored by University of Milan. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by University of Milan · Observational
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.
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.
37 studies on the registry are indexed under Hemoptysis; 6 are open to participants now.
This study's enrollment of 75 is below the median of 176 across 15 observational studies indexed under Hemoptysis.
Browse Hemoptysis studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with hemoptysis caused by endobronchial malignancies who need an endoscopic intervention (i.e Argon Plasma Coagulation) to stop the bleeding
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoptysis patients caused by endobronchial malignancies
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.
Also known as: APC
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
Time frame: 48 hours
Incidence of adverse events
Incidence of adverse events following bronchoscopic Argon Plasma Coagulation in the treatment of patients with hemoptysis and endobronchial malignancies
Time frame: 48 hours
Incidence of hemoptysis recurrences
Incidence of hemoptysis recurrences (number of relapses)
Time frame: 3,5 months
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
Time frame: 3,5 months
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).
Time frame: 48 hours
Ran from Aug 2018 to primary completion in Jul 2023, 59 months.
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This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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