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

NCT06742099 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ICT Malignant Pleural effusion
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusions (Mpe)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Malignant Pleural effusion with pleurodesis

ACTIVE COMPARATOR

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

Malignant Pleural effusion with only chest tube for drainage

ACTIVE COMPARATOR

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

Procedure: Intercostal chest tube

Interventions

Intercostal chest tube PROCEDURE

the use of chest tubes to drain malignant pleural effusion

Also known as: Pleurodesis

Malignant Pleural effusion with only chest tube for drainage; Malignant Pleural effusion with pleurodesis

Pleurodesis COMBINATION_PRODUCT

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

Malignant Pleural effusion with pleurodesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Myeloproliferative Disorder, Chronic, with Eosinophilia

Interventions

Pleurodesis

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Hussein E Mohamed, MD

CONTACT

+201222303172; husseinessam07@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 19, 2024
• Study Start: December 30, 2024
• Primary Completion: June 15, 2025
• Study Completion: September 30, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

EG (1)