Clinical trial NCT01125124: Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion
Official title: Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Keywords: Pleurodesis
Malignant pleural effusion
Silver Nitrate
Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chest pain on the first five days after pleurodesis
timeFrame: Along the first five days after treatment
measure: Chest pain after 10 days of pleurodesis
timeFrame: On the 10th day after the procedure.
measure: Chest pain after 30 days of pleurodesis
timeFrame: Within 30 days of the procedure
Secondary outcomes:
measure: Effectiveness of the pleurodesis
timeFrame: After 30 days of the procedure
measure: Dyspnea
timeFrame: Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure.
measure: Adverse effects
timeFrame: Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital Heart Institute
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Ricardo M Terra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paschoalini Mda S, Vargas FS, Marchi E, Pereira JR, Jatene FB, Antonangelo L, Light RW. Prospective randomized trial of silver nitrate vs talc slurry in pleurodesis for symptomatic malignant pleural effusions. Chest. 2005 Aug;128(2):684-9. doi: 10.1378/chest.128.2.684.