Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

Last updated: May 14, 2010
Sponsor: University of Sao Paulo General Hospital
Overall Status: Trial Status Unknown

Phase

2

Condition

Pleural Effusion

Lung Disease

Treatment

N/A

Clinical Study ID

NCT01125124
1041/09
1041/09
  • Ages 18-80
  • All Genders

Study Summary

The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleuralbiopsy.

  • Recurrent and symptomatic malignant pleural effusion.

  • Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.

  • Karnofsky Performance Status >30

  • Agreement to participate of the study by signing of the Informed Consent Term.

Exclusion

Exclusion Criteria:

  • Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).

  • Active pleural or systemic infection.

  • Massive skin neoplastic infiltration.

  • Inability of understanding the pain scale.

  • Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).

  • Refusal to participate of the study.

Study Design

Total Participants: 60
Study Start date:
August 01, 2009
Estimated Completion Date:
December 31, 2010

Study Description

Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents.

Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Connect with a study center

  • University of Sao Paulo General Hospital Heart Institute

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.