Prospective Evaluation of Patients With Pleural Effusion

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Effusion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ka Pang Chan, MBChB; Phone Number: 35052211; Email: chankapang@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: David SC Hui, MD; Phone Number: 852 2632 3128; Email: dschui@cuhk.edu.hk
    • Contact: Ka Pang Chan, MBChB; Phone Number: 852 3505 3396; Email: chankapang@cuhk.edu.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: David SC Hui, MD; Phone Number: 852 2632 3128; Email: dschui@cuhk.edu.hk
    • Contact: Ka Pang Chan, MBChB; Phone Number: 852 3505 3396; Email: chankapang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have pleural effusion and will undergo thoracentesis for pleural fluid sampling

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aetiology of pleural effusion	spectrum of aetiology for pleural effusion	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of pleural effusion	common clinical practice of handling pleural effusion will be evaluated	1 month
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: ProspectivePleuralEffusion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No