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Not yet recruiting NCT06964321

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

No phase Interventional Malignant Pleural Effusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intercostal tube drainage, big tail catheter drainage, ultrasound-guided aspiration.
Who it may be relevant to
Registry conditions: Malignant Pleural Effusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

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

Primary outcome measures

  • Resolution of Pleural Effusion [Time frame: baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06964321 · IT drainage-pigtail-US Aspirat

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗