Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

Assiut University

Status: Begins enrollment this month

Conditions: Malignant Pleural Effusion

Treatments: Procedure: Group 2 chemical pleurodesis by bleomycin); Procedure: Group 1 (mechanical pleurodesis)

Study type: Interventional

Funder types: Other

Identifiers

NCT06691009

Interventions for MPE

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Group 1 (Mechanical pleurodesis)

Experimental group

Description:

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, and 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.

Treatment:

Procedure: Group 1 (mechanical pleurodesis)

Group 2 (Chemical pleurodesis by bleomycin)

Experimental group

Description:

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.

Treatment:

Procedure: Group 2 chemical pleurodesis by bleomycin)