Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

Not Applicable

Not yet recruiting

• Conditions: Malignant Pleural Effusion

• Registration Number: NCT06691009
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-17
• Status Verified: 2024-10
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Study Start: 2024-12-10
• Primary Completion: 2029-08-10
• Study Completion: 2029-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients who are 18 years old or more.
• patients with rapidly accumulating moderate & massive malignant pleural. effusion that need frequent aspiration to relieve dyspnea and affect quality of life of the patient.

Exclusion Criteria

• patients not fit for thoracoscoy.
• patients with life expectency less than 1 month .
• trapped lung (endobronchial lesion).
• excessive pleural adhesios.
• mild effusion not need frequent aspiration and not affect
• quality of life .
• patients with chest infection : pneumonia , empyema .
• patients with performance status that doesn't expected to increase by 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Assessment of successful pleurodesis by chest ultrasound	6 months	This will be done every 2 weeks to detect any recollection of fluid in the pleural space. It will be used to determine whether the intervention achieved full or partial success

Trial Locations

Locations (1)

Assiut University Faculty of Medicine; 🇪🇬 Assiut, Egypt