Status:
UNKNOWN
AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion
Lead Sponsor:
The University of Western Australia
Collaborating Sponsors:
Sir Charles Gairdner Hospital
Fiona Stanley Hospital
Conditions:
Malignant Pleural Effusion
Respiratory Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. Who is it for? You may be eligible for this st...
Detailed Description
Participants will be randomly assigned (1:1) to one of two arms: Arm 1: Indwelling pleural catheter (with talc pleurodesis if suitable) Arm 2: Pleurodesis via Video-assisted thoracoscopic surgery Ar...
Eligibility Criteria
Inclusion
- Patients with a symptomatic MPE\*
- Predicted survival of more than 6 months
- 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
- Age \<18yrs;
- 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.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04322136
Start Date
May 29 2018
End Date
December 31 2025
Last Update
December 11 2023
Active Locations (1)
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1
Institute for Respiratory Health
Nedlands, Western Australia, Australia, 6009