Clinical trial NCT05759117: Prospective Evaluation of Patients With Pleural Effusion
Official title: Prospective Evaluation of the Aetiologies, Management and Clinical Outcomes in Patients With Pleural Effusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have pleural effusion and will undergo thoracentesis for pleural fluid sampling

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aetiology of pleural effusion
timeFrame: 1 month
Secondary outcomes:
measure: Management of pleural effusion
timeFrame: 1 month
measure: Prognosis of pleural effusion
timeFrame: 1 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: David SC Hui, MD
role: STUDY_DIRECTOR
References: