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NCT Number: NCT06742099

The Outcome of Inserting Intercostal Tube or Pleurodesis for Malignant Pleural Effusion

Approximately half of all patients with metastatic cancer develop a malignant pleural effusion which is likely to lead to a significant reduction in quality of life secondary to symptoms such as dyspnoea and cough. The aim of pleurodesis in these patients is to prevent re-accumulation of the effusion and thereby of symptoms,and avoid the need for repeated hospitalization for thoracocentesis. Numerous clinical studies have been performed to try to determine the optimal pleurodesis strategy, and synthesis of the available evidence should facilitate this. The treatment of MPE is aimed at palliating symptoms since no intervention has been shown to improve survival in this population and since survival is generally limited in cancers that have spread to the pleural space. In this palliative setting, only patients symptomatic from their MPE should be submitted to further intervention. As well, further interventions in symptomatic patients should be limited to those patients who have experienced symptomatic improvement following initial therapeutic thoracentesis. The two main treatment approaches to MPE are to obliterate the pleural space via a pleurodesis procedure or to chronically drain the pleural cavity with Intercostal tube. The aims of this review were to ascertain the optimal procedure in cases of malignant pleural effusion in terms of patients' quality of life post procedure, recurrence of effusion.

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Key information

Conditions

Malignant Pleural Effusions (Mpe) Myeloproliferative Disorder, Chronic, with Eosinophilia Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presented with malignant pleural effusion to Assiut University Hospital regardless of sex and age

Exclusion criteria

  • All patients presented with pleural effusion other than malignant pleural effusion, including patients with debilitating diseases and terminal patients.

Treatment and study plan

Intercostal chest tube

Procedure

the use of chest tubes to drain malignant pleural effusion

Other names: Pleurodesis

Pleurodesis

Combination Product

the injection of Talc in pleural space to induce inflammation reaction and produce pleurodesis

Primary outcomes

  1. chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments

    Time frame: from the time of intervention up to 6 months

    efficacy of both treatments, in which the treatment that shows less accumulation of pleural effusion in chest imaging gets better results hence is more effective than the other in terms of reducing Malignant Pleural effusion

  2. A questionnaire will be used to assess tolerability of both treatments on patients

    Time frame: from the time of intervention up to 6 months

    Tolerability, in which the questionnaire will include a score from 1 to 10 in which 1 is the lowest point and 10 is the highest point, it will include how painful each treatment is and how quality of life has changed after each treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Hussein E Mohamed, MD

CONTACT

[email protected]

+201222303172

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcome of Intercostal Tube Insertion and Pleurodesis for Malignant Pleural Effusion

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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