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Not yet recruitingNCT06742099Updated Dec 19, 2024

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

An Early Phase 1 interventional study of Intercostal chest tube and Pleurodesis in Malignant Pleural Effusions (Mpe), sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Assiut University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
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Study 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.

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Conditions studied

  • Malignant Pleural Effusions (Mpe)
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In context

Pleural Effusion, Malignant

169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 125 interventional studies indexed under Pleural Effusion, Malignant.

Browse Pleural Effusion, Malignant studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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 · Combination Product: 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

Interventions

  • ProcedureIntercostal chest tube

    the use of chest tubes to drain malignant pleural effusion

    Also known as: Pleurodesis

  • Combination productPleurodesis

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

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What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

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Study locations

1 site
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References and documents

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. PubMed 33222091 ↗
  • 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. PubMed 31804680 ↗
  • 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. PubMed 31525813 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06742099
Lead sponsor
Assiut University
Responsible party
Hussein Essameldin Hussein Mohamed (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Dec 19, 2024
Start date
Dec 30, 2024 (estimated)
Primary completion
Jun 15, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Dec 19, 2024

Study contacts

Hussein E Mohamed, MD
Contact
husseinessam07@gmail.com
+201222303172

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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