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NCT Number: NCT06691009

Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Faculty of Medicine

Asyut, 71515, Egypt

Location contact

Montaser G Zahran, Professor

CONTACT

[email protected]

01008951058 ext. 002

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Assessment of successful pleurodesis by chest ultrasound

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Montaser G Zahran, Professor

CONTACT

[email protected]

+201008951058

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effectiveness of Pleurodesis by Pleural Abrasion Using Medical Thoracoscopy Versus Bleomycin Via Pleural Catheter in Patients With Malignant Pleural Effusion

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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