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

Assiut University

Status: Not yet enrolling

Conditions: Malignant Pleural Effusion

Treatments: Procedure: ultrasound-guided aspiration; Procedure: intercostal tube drainage; Procedure: big tail catheter drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT06964321

IT drainage-pigtail-US Aspirat

Details and patient eligibility

About

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).

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Group A

Active Comparator group

Description:

intercostal tube drainage in managing massive malignant pleural effusion (MPE).

Treatment:

Procedure: intercostal tube drainage

Group B

Active Comparator group

Description:

big tail catheter drainage in managing massive malignant pleural effusion (MPE).

Treatment:

Procedure: big tail catheter drainage

Group C

Active Comparator group

Description:

ultrasound-guided aspiration in managing massive malignant pleural effusion (MPE).

Treatment:

Procedure: ultrasound-guided aspiration