Clinical trial NCT06742099: The Outcome of Inserting Intercostal Tube or Pleurodesis for Malignant Pleural Effusion
Official title: Outcome of Intercostal Tube Insertion and Pleurodesis for Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Pleural Effusions (Mpe)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: chest imaging, chest x-rays will be used to record the progress of the malignant pleural effusion in both treatments
timeFrame: from the time of intervention up to 6 months
measure: A questionnaire will be used to assess tolerability of both treatments on patients
timeFrame: from the time of intervention up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.