NCT06691009

Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

Effectiveness of Pleurodesis by Pleural Abrasion Using Medical Thoracoscopy Versus Bleomycin Via Pleural Catheter in Patients With Malignant Pleural Effusion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Comparision between pleurodesis by pleural abrasion using medical thoracoscopy and bleomycin instillation via indwelling pleural catheter. Evaluating the effectiveness of pleural abrasion using medical thoracoscopy in patients with malignant pleural effusion and evaluating the role of ROSE in diagnosis and management of malignant pleural effusion

Detailed description

Malignant pleural effusion cause significant morbidity so drainage effusion can provide great palliation and improve quality of life of these patients. There are several diagnostic tools for diagnosing malignant pleural effusion as pleural fluid cytology, closed pleural biopsy or thoracosopic pleural biopsy. Medical thoracoscopy has significant role in diagnosis and management of malignant pleural effusion. Also, pleurodesis may be performed through it by mechanical methods as pleural abrasion or chemical methods by talc poudrage, bleomycin or cisplatin instillation . and surgically through pleurectomy. Recently, using of ROSE (Rapis On-Site Examination) technique during medical thoracoscopy showed high accuracy for distinguishing between benign and malignant lesions, and this help in decision making. In our study, we will use mechanical pleurodesis by pleural abrasion using medical thoracoscpy and chemical pleurodesis by instillation of bleomycin via indwelling pleural catheter.

Conditions

• Malignant Pleural Effusion

Interventions

Type	Name	Description
PROCEDURE	Group 1 (mechanical pleurodesis)	pleural abrasions will be done by scrubbing the parietal and visceral pleura until a uniform aspect of bloody pleura by a piece of gauze attached to the end of a holding forceps , intercostal tube will then placed and monitoring of lung expansion will be done through serial CXR and chest ultrasound follow up and when the lung is fully expanded the tube will be clamped for two hours and follow up CXR will be done for follow up and then the tube removed
PROCEDURE	Group 2 chemical pleurodesis by bleomycin)	Those Patients will have indwelling pleural catheter through which pleural fluid will be drained until dryness and then pleurodesis will be done by 60 mg bleomycin dissolved in 50 ml 0.9% saline and 10 ml 2% xylocaine solution then the catheter will be clamped for 6 hours

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-08-10
• Completion: 2029-10-10
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: Egypt