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

NCT06964321 | Not Yet Recruiting

• 1 other identifier: IT drainage-pigtail-US Aspirat
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Resolution of Pleural Effusion

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

  baseline

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Procedure: intercostal tube drainage

Group B

ACTIVE COMPARATOR

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

Procedure: big tail catheter drainage

Group C

ACTIVE COMPARATOR

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

Procedure: ultrasound-guided aspiration

Interventions

intercostal tube drainage PROCEDURE

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

Group A

big tail catheter drainage PROCEDURE

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

Group B

ultrasound-guided aspiration PROCEDURE

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

Group C

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05