AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion

Launched by THE UNIVERSITY OF WESTERN AUSTRALIA · Mar 25, 2020

Keywords

ClinConnect Summary

The AMPLE-3 clinical trial is studying two different treatments for a condition called malignant pleural effusion, which is when fluid builds up in the space around the lungs due to cancer. The trial aims to find out whether a long-term catheter, which is a tube that helps drain the fluid, is more effective than a surgical procedure called pleurodesis, where doctors use a small incision to remove fluid and help the lung re-expand.

If you are an adult experiencing symptoms from this condition, such as difficulty breathing, and have a predicted survival of more than six months, you may be eligible to participate. Participants will be randomly assigned to either receive the catheter at home or undergo the surgery. Throughout the study, you will have follow-up visits to check your progress and answer questions about your quality of life. This research hopes to provide better symptom relief with less invasive treatments for people facing this serious issue.

Gender

ALL

Eligibility 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.