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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Drug: Silver Nitrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Recruiting
    • University of Sao Paulo General Hospital Heart Institute
    • Contact: Ricardo M Terra, MD; Phone Number: (55)1130696442; Email: rmterra@uol.com.br
    • Principal Investigator: Ricardo M Terra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Silver Nitrate 1; Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.	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.
EXPERIMENTAL: Silver Nitrate 2; Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.	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.
EXPERIMENTAL: Silver Nitrate 3; Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Chest pain after 10 days of pleurodesis	Chest pain will be assessed using the Visual Analog Scale	On the 10th day after the procedure.
Chest pain after 30 days of pleurodesis	Chest pain will be evaluated by Visual Analog Scale	Within 30 days of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Ricardo M Terra, MD, University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2010
• Study Completion (ANTICIPATED): December 1, 2010

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: May 14, 2010
• First Posted (ESTIMATE): May 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 18, 2010
• Last Update Submitted That Met QC Criteria: May 14, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Pain; Malignant pleural effusion; Pleurodesis; Silver Nitrate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Anti-Infective Agents, Local; Anti-Infective Agents; Silver Nitrate
• Other Study ID Numbers: 1041/09 (OTHER: University of Sao Paulo General Hospital Research Committee)