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

NCT ID: NCT06742099

Last Updated: 2024-12-19

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

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Pleural Effusions (Mpe)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Malignant Pleural effusion with pleurodesis

these are patients who have malignant pleural effusion and will have talc injected into the pleural cavity to induce pleurodesis

Group Type ACTIVE_COMPARATOR

Intercostal chest tube

Intervention Type PROCEDURE

the use of chest tubes to drain malignant pleural effusion

Pleurodesis

Intervention Type COMBINATION_PRODUCT

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

Malignant Pleural effusion with only chest tube for drainage

these are patients who have malignant pleural effusion but will only have intercostal chest tube inserted for drainage

Group Type ACTIVE_COMPARATOR

Intercostal chest tube

Intervention Type PROCEDURE

the use of chest tubes to drain malignant pleural effusion

Interventions

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Intercostal chest tube

the use of chest tubes to drain malignant pleural effusion

Intervention Type PROCEDURE

Pleurodesis

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Pleurodesis

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hussein Essameldin Hussein Mohamed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hussein E Mohamed, MD

Role: CONTACT

Phone: +201222303172

Email: [email protected]

References

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Beltsios ET, Mavrovounis G, Adamou A, Panagiotopoulos N. Talc pleurodesis in malignant pleural effusion: a systematic review and meta-analysis. Gen Thorac Cardiovasc Surg. 2021 May;69(5):832-842. doi: 10.1007/s11748-020-01549-2. Epub 2020 Nov 22.

Reference Type BACKGROUND
PMID: 33222091 (View on PubMed)

Bhatnagar R, Piotrowska HEG, Laskawiec-Szkonter M, Kahan BC, Luengo-Fernandez R, Pepperell JCT, Evison MD, Holme J, Al-Aloul M, Psallidas I, Lim WS, Blyth KG, Roberts ME, Cox G, Downer NJ, Herre J, Sivasothy P, Menzies D, Munavvar M, Kyi MM, Ahmed L, West AG, Harrison RN, Prudon B, Hettiarachchi G, Chakrabarti B, Kavidasan A, Sutton BP, Zahan-Evans NJ, Quaddy JL, Edey AJ, Clive AO, Walker SP, Little MHR, Mei XW, Harvey JE, Hooper CE, Davies HE, Slade M, Sivier M, Miller RF, Rahman NM, Maskell NA. Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial. JAMA. 2020 Jan 7;323(1):60-69. doi: 10.1001/jama.2019.19997.

Reference Type BACKGROUND
PMID: 31804680 (View on PubMed)

Toth JW, Reed MF, Ventola LK. Chest Tube Drainage Devices. Semin Respir Crit Care Med. 2019 Jun;40(3):386-393. doi: 10.1055/s-0039-1694769. Epub 2019 Sep 16.

Reference Type BACKGROUND
PMID: 31525813 (View on PubMed)

Other Identifiers

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ICT Malignant Pleural effusion

Identifier Type: -

Identifier Source: org_study_id