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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01125124
• Other study ID #: 1041/09
• Secondary ID: 1041/09
• Status: Recruiting
• Phase: Phase 2
• First received: April 26, 2010
• Last updated: May 14, 2010
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Silver Nitrate
Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital Heart Institute	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest pain on the first five days after pleurodesis	Chest pain will be evaluated via Visual Analog Scale.	Along the first five days after treatment	No
Primary	Chest pain after 10 days of pleurodesis	Chest pain will be assessed using the Visual Analog Scale	On the 10th day after the procedure.	No
Primary	Chest pain after 30 days of pleurodesis	Chest pain will be evaluated by Visual Analog Scale	Within 30 days of the procedure	No
Secondary	Effectiveness of the pleurodesis	On hospital discharge, five days after the procedure, patients are submitted to chest computerized tomography (CT). After 30 days of the procedure, patients are submitted to another chest CT and the volume of pleural effusion is calculated and compared to that of the hospital discharge date (calculated by the 5th day CT).	After 30 days of the procedure	No
Secondary	Dyspnea	Dyspnea will be evaluated through the British MRC dyspnea scale.	Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure.	No
Secondary	Adverse effects	The safety of the treatment will be assessed both by monitoring of complete blood counts, renal function, liver function and inflammation markers, as well as monitoring of body temperature, arterial blood pressure and heart rate. The occurrence of adverse side effects will be assessed using the United States National Cancer Institute Common Terminology Criteria for Adverse Events v.3.0.	Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure	Yes