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

NCT06742099 — Early Phase 1, Not yet recruiting, 20 participants, Assiut University

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Outcome of Intercostal Tube Insertion and Pleurodesis for Malignant Pleural Effusion

RegistryNCT06742099
StatusNot yet recruiting
PhaseEarly Phase 1
Study typeInterventional; randomized, single group, masking: none, treatment
Enrollment20 (Estimated)
SponsorAssiut University (Other)
ConditionsMalignant Pleural Effusions (Mpe)
InterventionsIntercostal chest tube, Pleurodesis (Procedure, combination product)
Datesstart 2024-12-30 (estimated), primary completion 2025-06-15 (estimated), completion 2025-09-30 (estimated), first posted 2024-12-19, last updated 2024-12-19
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Malignant Pleural Effusions (Mpe) All trials of Intercostal chest tube All trials of Pleurodesis

-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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+Arms and interventions

ArmTypeInterventionsDescription
Malignant Pleural effusion with pleurodesisActive comparatorProcedure: Intercostal chest tube; Combination Product: Pleurodesisthese are patients who have malignant pleural effusion and will have talc injected into the pleural cavity to induce pleurodesis
Malignant Pleural effusion with only chest tube for drainageActive comparatorProcedure: Intercostal chest tubethese are patients who have malignant pleural effusion but will only have intercostal chest tube inserted for drainage
  • Intercostal chest tube (Procedure), also known as Pleurodesis: the use of chest tubes to drain malignant pleural effusion
  • Pleurodesis (Combination product): the injection of Talc in pleural space to induce inflammation reaction and produce pleurodesis

+Outcome measures

Primary outcomes

  • chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments [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
  • A questionnaire will be used to assess tolerability of both treatments on patients [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

+Eligibility

Sex: All

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.

+Locations (1)

FacilityCityCountryStatus
Assiut University HospitalAsyut, Asyut GovernorateEgypt

+Publications

  • Results publication: 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. PMID 33222091
  • Results publication: 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. PMID 31804680
  • Results publication: 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. PMID 31525813