Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

N/ANot Yet RecruitingNCT06691009

Assiut University70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Malignant Pleural Effusion

Interventions

Group 1 (mechanical pleurodesis)PROCEDURE

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

Group 2 chemical pleurodesis by bleomycin)PROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Assiut University Faculty of Medicine

Asyut, Egypt

Outcomes

Primary Outcomes

Assessment of successful pleurodesis by chest ultrasound

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

Time frame: 6 months

Central Contacts

Montaser G Zahran, Professor

CONTACT

+201008951058 montaser_zahran@yahoo.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.