About this trial
Pleural effusion is characterized by the accumulation of fluid in the pleural space, which typically contains about 10-20 mL of pleural fluid that is crucial for the movement of the lungs against the chest wall. This fluid closely resembles plasma but has a lower protein concentration, usually less than 1.5 gm/dL. It primarily originates from pleural capillaries and the interstitial spaces of the lung, and is reabsorbed through the lymphatic vessels in the parietal pleura, either via small openings known as stomas or through a process called transcytosis (1, 2). When the balance between fluid production and reabsorption is disrupted-often due to various pathogenic mechanisms-it can lead to pleural effusion. In such cases, effective management is essential. This study aims to conduct a thorough comparison of the two talc administration methods-TS and TI-using sterilized, large-particle, asbestos-free talc powder. By examining key outcome measures such as pleurodesis success rates, procedural morbidity, and length of hospital stay, the goal is to provide clinicians with evidence-based guidance to facilitate informed decision-making in the management of pleural effusions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 12 years and older.
Diagnosed with malignant pleural effusions or pneumothoraces.
ECOG performance status of 0-2.
Life expectancy of at least 3 months.
Disqualifiers
Patients younger than 12 years old
Female patients who are pregnant or lactating
Patients with encysted or septated pleural effusions and pneumothoraces
Patients presenting with respiratory failure
Trial design
Parallel
Treatments tested in this trial
Pleurodesis
Procedure/SurgeryTalc slurry pleurodesis is a chemical technique for managing recurrent pleural effusions and pneumothoraces. The procedure involves instilling a suspension of talc (4-5 grams) in sterile saline (50-100 mL) into the pleural space via a chest tube. This induces an inflammatory reaction, leading to fibrosis and fusion of pleural surfaces. The technique demonstrates 70-90% success rates in malignant pleural effusions and pneumothoraces, with efficacy comparable to talc poudrage. While generally safe, potential complications include pain, fever, and rarely, pneumonitis or empyema. Use of large-particle, asbestos-free talc and standardized protocols has improved its safety profile.
pleurodesis
Procedure/SurgeryTalc insufflation, is a pleurodesis technique involving direct insufflation of dry talc powder into the pleural cavity during thoracoscopy. It allows visual inspection of the pleural space and concurrent diagnostic procedures. Success rates range from 85% to 93% for malignant pleural effusions and pneumothoraces, with efficacy comparable or potentially superior to talc slurry in some studies. The procedure typically requires general anesthesia and is more invasive than talc slurry. Common side effects include chest pain, fever, and dyspnea. The risk of severe respiratory complications has decreased with large-particle, asbestos-free talc. While effective, the choice between insufflation and slurry depends on patient factors, institutional expertise, and resource availability.
Treatment groups
Trial outcomes
Primary outcomes
Success of Pleurodesis
The success rate of pleurodesis is defined as the percentage of patients who achieve complete resolution of pleural effusion or pneumothorax within a specified time frame of 01 months post-procedure. Success is assessed through follow-up chest radiographs, with criteria for success including the absence of fluid reaccumulation or lung collapse during this period. Clinical improvement in symptoms such as dyspnea may also be considered as supplementary evidence of a successful outcome.
Secondary outcomes
Procedural Morbidity of pleurodesis
Procedural morbidity refers to the incidence and severity of complications directly attributable to the pleurodesis procedure, occurring within 30 days post-procedure.
Sponsors and contacts
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