Comparing two methods for treating malignant pleural effusion
The Australasian Malignant PLeural Effusion (AMPLE) Trial - 3: A Randomised Study of the Relative Benefits of Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis Therapy or Video-Assisted Thoracoscopic Surgery (VATS) in the Management of Patients With Malignant Pleural Effusion.
NA · The University of Western Australia · NCT04322136
This study is testing whether a long-term catheter or surgery works better for helping people with fluid buildup in the lungs due to cancer feel better and breathe easier.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Western Australia (other) |
| Locations | 1 site (Nedlands, Western Australia) |
| Trial ID | NCT04322136 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an indwelling pleural catheter versus surgical pleurodesis in managing malignant pleural effusion. Participants will be randomly assigned to one of two treatment arms: one receiving a long-term catheter for home drainage and the other undergoing video-assisted thoracoscopic surgery. The study will monitor participants' quality of life and clinical outcomes over a year, with follow-up assessments at various intervals. The goal is to determine which method provides better symptom relief and lung function restoration.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic malignant pleural effusion and a predicted survival of more than six months.
Not a fit: Patients who are under 18 years old, unfit for surgery, or have certain medical conditions like pleural infection or chylothorax may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and less invasive treatment option for managing malignant pleural effusion.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a symptomatic MPE\* 2. Predicted survival of more than 6 months 3. Eastern Cooperative Oncology Group (ECOG) score = Peformance status defined as a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc. ECOG 0-1 (or ECOG greater than or equal to 2 if it is felt that removal of pleural fluid would improve their status to 0 or 1). * MPE is defined as histologically/cytologically proven pleural malignancy or an otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere. Exclusion Criteria: 1. Age \<18yrs; 2. Unfit to undergo a surgical procedure (American Society of Anaesthesiologists Score \>/=4); 3. Pleural infection; 4. Chylothorax; 5. Pregnancy or lactation; 6. Uncorrectable bleeding diathesis; 7. Previous ipsilateral lobectomy/pneumonectomy; 8. Inability to consent or comply with protocol.
Where this trial is running
Nedlands, Western Australia
- Institute for Respiratory Health — Nedlands, Western Australia, Australia (RECRUITING)
Study contacts
- Study coordinator: YC Gary Lee, MBChB PhD
- Email: gary.lee@uwa.edu.au
- Phone: +61861510913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Pleural Effusion, Respiratory Disease, Cancer