Clinical trial NCT06691009: Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion
Official title: Effectiveness of Pleurodesis by Pleural Abrasion Using Medical Thoracoscopy Versus Bleomycin Via Pleural Catheter in Patients With Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Pleural Effusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited and after final diagnosis. This will be done by crossover method 1:1. Patients with ODD number will be included in group 1, and patients with even number will be included in group 2.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of successful pleurodesis by chest ultrasound
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Faculty of Medicine
Study officials:
affiliation: Assiut University Faculty of Medicine
name: Mohamed M Abd ElHady, Professor
role: STUDY_DIRECTOR
References:
citation: Bibby AC, Dorn P, Psallidas I, Porcel JM, Janssen J, Froudarakis M, Subotic D, Astoul P, Licht P, Schmid R, Scherpereel A, Rahman NM, Cardillo G, Maskell NA. ERS/EACTS statement on the management of malignant pleural effusions. Eur Respir J. 2018 Jul 27;52(1):1800349. doi: 10.1183/13993003.00349-2018. Print 2018 Jul.
citation: LoCicero J 3rd. Thoracoscopic management of malignant pleural effusion. Ann Thorac Surg. 1993 Sep;56(3):641-3. doi: 10.1016/0003-4975(93)90937-d.
citation: Hamouda D, Elsayed E, Alawady SM. Pleurodesis Using Bleomycin Ampoules, Doxycycline Capsules, and Povidone Iodine Solution in Patients with Malignant Pleural Effusion in Zagazig University Hospitals. 2022;28(5):1022-8.