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

Outcome of Intercostal Tube Insertion and Pleurodesis for Malignant Pleural Effusion

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06742099
Enrollment
20
Registered
2024-12-19
Start date
2024-12-30
Completion date
2025-09-30
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Effusions (Mpe)

Brief summary

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.

Interventions

PROCEDUREIntercostal chest tube

the use of chest tubes to drain malignant pleural effusion

COMBINATION_PRODUCTPleurodesis

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

2.4.1- Type of the study: Retrospective and Prospective 2.4. 2- Study Setting: All patients with malignant pleural effusion and either underwent intercostal tube insertion or had pleurodesis done in 2 to 3 years' timeframe. 2.4. 3- Study subjects: 1. Inclusion criteria: All patients presented with malignant pleural effusion to Assiut University Hospital regardless of sex And age 2. Exclusion criteria: All patients presented with pleural effusion other than malignant pleural effusion, including patients with debilitating diseases and terminal patients. 3. Sample Size Calculation: Sample size calculation was carried out using G\* Power 3 software. To detect significant differences between both groups as regard post-operative complications with expected frequency of 14.5-16.7% and based on the following parameters: an error probability of 0.05 and 80% power on a two-tailed test, a calculated minimum required sample of 110 patients will be required.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatmentsfrom the time of intervention up to 6 monthsefficacy 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
A questionnaire will be used to assess tolerability of both treatments on patientsfrom the time of intervention up to 6 monthsTolerability, 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

Countries

Egypt

Contacts

Primary ContactHussein E Mohamed, MD
husseinessam07@gmail.com+201222303172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026