Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2029-10-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

There will be an outcome assessor who do not know which group recieved which treatment. Also, the participants will not know to which group they will be included.

Study Groups

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Group 1 (Mechanical pleurodesis)

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.

Group Type EXPERIMENTAL

Group 1 (mechanical pleurodesis)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Group 2 chemical pleurodesis by bleomycin)

Intervention Type 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

Interventions

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Group 1 (mechanical pleurodesis)

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

Intervention Type PROCEDURE

Group 2 chemical pleurodesis by bleomycin)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No