Effectiveness of Intercostal Tube Drainage Vs Pigtail Catheter Drainage Vs Ultrasound-Guided Aspiration in Management of Massive Malignant Pleural Effusion

NCT06964321 — Not applicable, Not yet recruiting, 66 participants, Assiut University

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Registry	NCT06964321
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	66 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Malignant Pleural Effusion
Interventions	intercostal tube drainage, big tail catheter drainage, ultrasound-guided aspiration (Procedure)
Dates	start 2025-06-01 (estimated), primary completion 2026-06-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-05-09, last updated 2025-05-09

-Summary

Pleural effusion is common in different diseases and especially malignant effusions can have fast onset symptoms such as chest pain, dyspnoea, and coughing. Malignant pleural effusion (MPE) is an exudative effusion with malignant cells.

It is a common symptom and accompanying presentation of metastatic disease. It Impacts up to 15% of all patients with cancer and is the most common in breast, lung, cancer, lymphoma, and gynaecological malignancies . There are 150,000 new cases of MPE in the United States yearly and 100,000 in Europe . Patients have an overall survival (OS) rate of 3-12 months after the initial diagnosis . Malignant pleural effusion (MPE) poses significant challenges in management, impacting patient quality of life and overall prognosis. Almost all radiological procedures can help diagnose pleural effusions . Thoracentesis is used as a diagnostic and therapeutic tool. The procedure has been modified with the addition of ultrasound, that is very functional for targeting certain anatomical areas of the pleura and finding an appropriate entry point . Three primary strategies are commonly employed: intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration. This study aims to evaluate these methods' efficacy, safety, and outcomes. To compare intercostal tube drainage, big tail catheter drainage, and ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

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+Arms and interventions

Arm	Type	Interventions	Description
Group A	Active comparator	Procedure: intercostal tube drainage	intercostal tube drainage in managing massive malignant pleural effusion (MPE).
Group B	Active comparator	Procedure: big tail catheter drainage	big tail catheter drainage in managing massive malignant pleural effusion (MPE).
Group C	Active comparator	Procedure: ultrasound-guided aspiration	ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

intercostal tube drainage (Procedure): intercostal tube drainage in managing massive malignant pleural effusion (MPE).
big tail catheter drainage (Procedure): big tail catheter drainage in managing massive malignant pleural effusion (MPE).
ultrasound-guided aspiration (Procedure): ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

+Outcome measures

Primary outcomes

Resolution of Pleural Effusion [baseline]: Resolution of Pleural Effusion: Defined as complete or partial resolution based on imaging studies (e.g., chest X-ray or ultrasound).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patient aged 18 years old and above.
* Patients diagnosed with massive malignant pleural effusion (MPE) requiring intervention.

Exclusion Criteria:

* Pediatric patients aged below 18 years
* Patients with non-malignant causes of pleural effusion.