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A randomized controlled, multicenter, open-label phase I/II study to evaluate the safety, efficacy of drainage volumes over 24 hours of an indwelling pleural catheter (IPC) for malignant pleural effusions

A randomized controlled, multicenter, open-label phase I/II study to evaluate the safety, efficacy of drainage volumes over 24 hours of an indwelling pleural catheter (IPC) for malignant pleural effusions

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082107
Enrollment
Unknown
Registered
2024-03-20
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Effusions

Interventions

control group:First 24-hour drainage of 1000ml
treatment group:First 24-hour drainage of 1500ml
treatment group:First 24-hour drainage of 2000ml
treatment group:First 24-hour drainage of 2500ml

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with MPE with symptoms of dyspnoea who are considered by the investigators to have an indication for fluid drainage via IPC; 2. Imaging such as ultrasound or CT suggests that the volume of pleural effusion is =3000ml; 3. Predicted survival ?6 months.

Exclusion criteria

Exclusion criteria: 1. Patients = 18 years of age; 2. Chest wall disease that may prevent effective drainage via closed chest drainage (IPC); pleural infection; celiac disease; pregnancy or breastfeeding; 3. Uncorrectable bleeding tendency; 4. Those who are unable to obtain informed consent or comply with the trial protocol.

Design outcomes

Primary

MeasureTime frame
Vital signs, laboratory tests, and any other adverse events, including type, incidence, severity, time, etc,with severity assessed with reference to CTCAE (version 5.0);

Secondary

MeasureTime frame
Dyspnoea relief rate;Cough relief rate;Accelerated heart rate mitigation rate;

Countries

China

Contacts

Public ContactYongsheng Wang

West China Hospital of Sichuan University

wangys@scu.edu.cn+86 189 8060 2258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026