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

NCT01125124 | Unknown Phase 2 DMC

• 1 other identifier: 1041/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion

Keywords

Pleurodesis; Malignant pleural effusion; Silver Nitrate; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Effectiveness of the pleurodesis

  After 30 days of the procedure

• Dyspnea

  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

  Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure

Study Arms (3)

Silver Nitrate 1

ACTIVE COMPARATOR

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

Drug: Silver Nitrate

Silver Nitrate 2

EXPERIMENTAL

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

Drug: Silver Nitrate

Silver Nitrate 3

EXPERIMENTAL

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

Drug: Silver Nitrate

Interventions

Silver Nitrate 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 1; Silver Nitrate 2; Silver Nitrate 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related 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. doi: 10.1378/chest.128.2.684.

  PMID: 16100154 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Pain

Interventions

Silver Nitrate

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds

Study Officials

• Ricardo M Terra, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 18, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2010-04

Locations

BR (1)