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Not yet recruitingNCT06964321Updated May 9, 2025

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

An interventional study of intercostal tube drainage and big tail catheter drainage in Malignant Pleural Effusion, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Malignant Pleural Effusion
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pediatric patients aged below 18 years
  • Patients with non-malignant causes of pleural effusion.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Group A

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

    Procedure: intercostal tube drainage

  • Active comparator
    Group B

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

    Procedure: big tail catheter drainage

  • Active comparator
    Group C

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

    Procedure: ultrasound-guided aspiration

Interventions

  • Procedureintercostal tube drainage

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

  • Procedurebig tail catheter drainage

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

  • Procedureultrasound-guided aspiration

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

05

What researchers measure

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).

    Time frame: baseline

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06964321
Lead sponsor
Assiut University
Responsible party
Mark Badrat William Mansour (residant doctor, Assiut University) — Principal investigator
First posted
May 9, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
May 9, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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