Prospective Evaluation of Patients With Pleural Effusion

Pleural Effusion Clinical Trial

Official title:

Prospective Evaluation of the Aetiologies, Management and Clinical Outcomes in Patients With Pleural Effusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759117
• Other study ID #: ProspectivePleuralEffusion
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Ka Pang Chan, MBChB
• Phone: 35052211
• Email: chankapang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Having a pleural effusion is a common reason for being hospitalized, as it usually requires in-patient care for invasive diagnostic and therapeutic procedures. Specific subtypes of pleural effusion may warrant recurrent admissions, a longer hospital stay and consume more healthcare resources. Despite the recent advancement of pleural medicine, better research is increasingly desired to fill the gaps in establishing an early diagnosis and optimal management of pleural effusion from various causes. Local data on different aspects of pleural effusion is also lacking.

Description:

The aetiologies of pleural effusion range from cardio-respiratory diseases, malignancy, infection to systemic inflammatory conditions. However, data on the exact incidence of individual causes of pleural effusion is inadequate. Conflicting results on the aetiologies of pleural effusion were shown in several retrospective and prospective studies based in different geographical regions, which may be explained by the different epidemiology of common diseases in the corresponding areas and patients recruited. Despite a common clinical problem, the incidence and aetiology of pleural effusion have not been examined on a population level in Hong Kong. Therefore, a local study is necessary to inform physicians about the disease burden of pleural effusion.

The management of pleural disease can be heterogeneous, as reflected by a recent multi-institutional questionnaire study in Hong Kong. Infrequent updates of international guidelines of pleural medicine, lack of an established registry reflecting the patient burden, procedure load and complications may contribute. Delayed or suboptimal management of pleural diseases can lead to unnecessary invasive procedures, prolonged hospital stays and even higher mortality rates. A local registry should be established to stocktake and understand diagnostic accuracy and complication rates of pleural procedures and reflects the real-life practice by hospital physicians.

This prospective study aims at evaluating the aetiology and management of pleural diseases prospectively. The management by the attending doctors will not be interfered. Recruited patients will be divided into subgroups based on their characteristics for further analysis. The data collected from this study will guide the planning of subsequent research to overcome the knowledge and service gap in managing pleural diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized for pleural effusion.

• Pleural tapping will be performed for pleural fluid analysis.

• Aged 18 years old or above

Exclusion Criteria:

• Failed to obtain informed consent due to the patient's refusal or cognitive impairment

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Procedure:
• thoracentesis
A type of pleural procedure that will yield pleural fluid for subsequent analysis

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aetiology of pleural effusion	spectrum of aetiology for pleural effusion	1 month
Secondary	Management of pleural effusion	common clinical practice of handling pleural effusion will be evaluated	1 month
Secondary	Prognosis of pleural effusion	need for hospitalization, pleural procedure, complication rate and time required to establish a diagnosis for patients with pleural effusion will be evaluated	1 month