Prospective Evaluation of Patients With Pleural Effusion

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05759117

Collaborator

(none)

1,000

Enrollment

Locations

Anticipated Duration (Months)

500

Patients Per Site

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion	Procedure: thoracentesis

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Pleural effusion All patients with pleural effusion who will undergo thoracentesis	Procedure: thoracentesis A type of pleural procedure that will yield pleural fluid for subsequent analysis Other Names: chest drain insertion

Arm

Intervention/Treatment

Pleural effusion

All patients with pleural effusion who will undergo thoracentesis

Procedure: thoracentesis

A type of pleural procedure that will yield pleural fluid for subsequent analysis

Other Names:

chest drain insertion

Outcome Measures

Primary Outcome Measures

Aetiology of pleural effusion [1 month]
spectrum of aetiology for pleural effusion

Secondary Outcome Measures

Management of pleural effusion [1 month]
common clinical practice of handling pleural effusion will be evaluated
Prognosis of pleural effusion [1 month]
need for hospitalization, pleural procedure, complication rate and time required to establish a diagnosis for patients with pleural effusion will be evaluated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese University of Hong Kong	Hong Kong		Hong Kong
2	Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Study Director: David SC Hui, MD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ka Pang Chan, Clinical Lecturer, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05759117

Other Study ID Numbers:

ProspectivePleuralEffusion

First Posted:

Mar 8, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pleural Effusion

Study Results

No Results Posted as of Mar 13, 2023