Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

ConditionMalignant Pleural Effusion

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

patients not fit for thoracoscoy.

patients with life expectency less than 1 month .

trapped lung (endobronchial lesion).

excessive pleural adhesios.

Trial design

Design model

Crossover

Treatments tested in this trial

Group 1 (mechanical pleurodesis)
Procedure/Surgery
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/Surgery
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 groups

70 Participants

are divided into 2 treatment groups

Group A: Group 1 (Mechanical pleurodesis)Experimental treatment 1 intervention

Group B: Group 2 (Chemical pleurodesis by bleomycin)Experimental treatment 1 intervention

Trial 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

Sponsors and contacts

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Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: