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

NCT03625947 | Terminated DMC

• 1 other identifier: Argon
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoptysis; Cancer

Keywords

Hemoptysis; Lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of adverse events

  48 hours

• Incidence of hemoptysis recurrences

  3,5 months

• Number of patients with hemoptysis and endobronchial malignancies who are still alive at the end of the follow-up

  3,5 months

• Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention

  48 hours

Study Arms (1)

Hemoptysis patients

Hemoptysis patients caused by endobronchial malignancies

Other: Argon Plasma Coagulation

Interventions

Argon Plasma Coagulation OTHER

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

Hemoptysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Michele Mondoni

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Hemoptysis; Neoplasms; Lung Neoplasms

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Michele Mondoni, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 10, 2018
• Study Start: August 8, 2018
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

IT (1)