Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

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

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Procedure: Group 1 (mechanical pleurodesis); Procedure: Group 2 chemical pleurodesis by bleomycin)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Montaser G Zahran, Professor; Phone Number: +201008951058; Email: montaser_zahran@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Faculty of Medicine
    • Contact: Montaser G Zahran, Professor; Phone Number: 002 01008951058; Email: montaser_zahran@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed M Abd ElHady, Professor, Assiut University Faculty of Medicine

Publications and helpful links

General Publications

• Bibby AC, Dorn P, Psallidas I, Porcel JM, Janssen J, Froudarakis M, Subotic D, Astoul P, Licht P, Schmid R, Scherpereel A, Rahman NM, Cardillo G, Maskell NA. ERS/EACTS statement on the management of malignant pleural effusions. Eur Respir J. 2018 Jul 27;52(1):1800349. doi: 10.1183/13993003.00349-2018. Print 2018 Jul.
• LoCicero J 3rd. Thoracoscopic management of malignant pleural effusion. Ann Thorac Surg. 1993 Sep;56(3):641-3. doi: 10.1016/0003-4975(93)90937-d.
• Hamouda D, Elsayed E, Alawady SM. Pleurodesis Using Bleomycin Ampoules, Doxycycline Capsules, and Povidone Iodine Solution in Patients with Malignant Pleural Effusion in Zagazig University Hospitals. 2022;28(5):1022-8.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): August 10, 2029
• Study Completion (Estimated): October 10, 2029

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Diseases; Pleural Effusion, Malignant; Pleural Effusion; Antibiotics, Antineoplastic; Antineoplastic Agents; Bleomycin
• Other Study ID Numbers: Interventions for MPE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No