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

NCT ID: NCT01125124

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

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.

Conditions

Malignant Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Silver Nitrate 1

Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.

Group Type: ACTIVE_COMPARATOR

Silver Nitrate

Intervention Type: DRUG

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.

Silver Nitrate 2

Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.

Group Type: EXPERIMENTAL

Silver Nitrate

Intervention Type: DRUG

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.

Silver Nitrate 3

Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.

Group Type: EXPERIMENTAL

Silver Nitrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

INCOR-HCFMUSP

Principal Investigators

Ricardo M Terra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

University of Sao Paulo General Hospital Heart Institute

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Ricardo M Terra, MD

Role: primary

rmterra@uol.com.br

(55)1130696442

References

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.

Reference Type: BACKGROUND

PMID: 16100154 (View on PubMed)

Other Identifiers

1041/09

Identifier Type: OTHER

Identifier Source: secondary_id

1041/09

Identifier Type: -

Identifier Source: org_study_id