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Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Malignant Pleural Effusion

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Trial Information

Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.


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.


Inclusion Criteria:



- Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or
pleural biopsy.

- 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Chest pain on the first five days after pleurodesis

Outcome Description:

Chest pain will be evaluated via Visual Analog Scale.

Outcome Time Frame:

Along the first five days after treatment

Safety Issue:

No

Principal Investigator

Ricardo M Terra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Sao Paulo General Hospital

Authority:

Brazil: National Health Surveillance Agency

Study ID:

1041/09

NCT ID:

NCT01125124

Start Date:

August 2009

Completion Date:

December 2010

Related Keywords:

  • Malignant Pleural Effusion
  • Pleurodesis
  • Malignant pleural effusion
  • Silver Nitrate
  • Pain
  • Pleural Effusion
  • Pleural Effusion, Malignant

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