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

NCT ID: NCT06964321

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

intercostal tube drainage

Intervention Type PROCEDURE

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

Group B

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

Group Type ACTIVE_COMPARATOR

big tail catheter drainage

Intervention Type PROCEDURE

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

Group C

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

Group Type ACTIVE_COMPARATOR

ultrasound-guided aspiration

Intervention Type PROCEDURE

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

Interventions

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intercostal tube drainage

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

Intervention Type PROCEDURE

big tail catheter drainage

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

Intervention Type PROCEDURE

ultrasound-guided aspiration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mark Badrat William Mansour

residant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IT drainage-pigtail-US Aspirat

Identifier Type: -

Identifier Source: org_study_id

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