Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

NCT06691009 | Not Yet Recruiting

• 1 other identifier: Interventions for MPE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1 (Mechanical pleurodesis)

EXPERIMENTAL

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)

Group 2 (Chemical pleurodesis by bleomycin)

EXPERIMENTAL

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)

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 1 (Mechanical pleurodesis)

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

Group 2 (Chemical pleurodesis by bleomycin)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Faculty of Medicine

Asyut, 71515, Egypt

Location

Related Publications (3)

• 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.

  PMID: 30054348 BACKGROUND

• 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.

  PMID: 8379759 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed M Abd ElHady, Professor

  Assiut University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Montaser G Zahran, Professor

CONTACT

+201008951058; montaser_zahran@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of chest diseases

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: November 15, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): August 10, 2029
• Study Completion (Estimated): October 10, 2029
• Last Updated: November 15, 2024

Record last verified: 2024-10

Locations

EG (1)