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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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 study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion. Study details Consenting participants will be randomised to one of two treatment arms: * Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home. * Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion. Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge. It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Institute for Respiratory Health
RECRUITING
Nedlands
Contact Information
Primary
YC Gary Lee, MBChB PhD
gary.lee@uwa.edu.au
+61861510913
Backup
Calvinjit Sidhu, MBBS
calvinjit.sidhu@health.wa.gov.au
+61437672808
Time Frame
Start Date: 2018-05-29
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 160
Treatments
Other: IPC (with talc pleurodesis if suitable)
The patients will undertake daily drainage to day 14 post insertion. The drainage will either be performed by the participant's carer or nurses in the community. A bottle or bag will be attached to the drain to allow for removal of accumulated pleural fluid. Once completed the drain will be reattached to the pleural catheter.~Participants will be taught how to perform pleural drainage by the main study doctor at the hospital or a specialist nurse. They will drain their own IPCs at home with the either the help of a family member or friend or have access to community nursing support systems.
Other: Pleurodesis via VATS
Participants will undergo VATS within two weeks of randomisation. VATS is usually performed in an operating theatre, using either general anaesthesia or local anaesthesia with sedation. The pleural fluid will be removed and adhesions can be divided (adhesiolysis). Assessment of lung re-expansion will be performed intra-operatively. If lung re-expansion is adequate (as judged by the operating surgeon), a variety of techniques may be employed to induce a pleurodesis, including, but not limited to, talc poudrage and mechanical abrasion. Decortication may be performed if deemed appropriate and feasible by the operating surgeon. A chest drain will be left in situ after the surgery. Post-operative care will be administered as per local practice.
Related Therapeutic Areas
Sponsors
Collaborators: Sir Charles Gairdner Hospital, Vanderbilt University Medical Center, Westmead Hospital, Australia, John Hunter Hospital, Hollywood Private Hospital, Australia, Sunshine Coast Hospital and Health Service, St Vincent's Hospital Melbourne, Wesley Hospital, Australia, Wellington Hospital, St John of God Midland Hospital, Australia, Royal Adelaide Hospital, Australia, Universiti Kebangsaan Malaysia Medical Centre, The Prince Charles Hospital, The Sutherland and St George Hospitals, Australia, Toronto General Hospital, Northern Hospital, Australia, Fiona Stanley Hospital, St John of God Murdoch Hospital, Australia, Guy's and St Thomas' NHS Foundation Trust, Auckland City Hospital, Johns Hopkins University, Concord Hospital, Hospital Queen Elizabeth, Malaysia
Leads: The University of Western Australia

This content was sourced from clinicaltrials.gov