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

Outcome of Intercostal Tube Insertion and 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Pleural Effusions (Mpe)
• Intervention / Treatment: Procedure: Intercostal chest tube; Combination product: Pleurodesis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hussein E Mohamed, MD; Phone Number: +201222303172; Email: husseinessam07@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Intercostal chest tube; the use of chest tubes to drain malignant pleural effusion; Other Names: Pleurodesis; Combination product: Pleurodesis; the injection of Talc in pleural space to induce inflammation reaction and produce pleurodesis
Active Comparator: 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	Procedure: Intercostal chest tube; the use of chest tubes to drain malignant pleural effusion; Other Names: Pleurodesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments	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	from the time of intervention up to 6 months
A questionnaire will be used to assess tolerability of both treatments on patients	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	from the time of intervention up to 6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Diseases; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: ICT Malignant Pleural effusion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No