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Pleural Bleomycin vs Mechanical Abrasion in Malignant Pleural Effusion

NCT06691009 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed M Abd ElHady, Professor · Assiut University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2029-08-10
Completion
2029-10-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06691009 on ClinicalTrials.gov