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

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.

Conditions

• Malignant Pleural Effusion
• Respiratory Disease
• Cancer

Interventions

PROCEDURE

Pleurodesis via Video-assisted thoracoscopic surgery

Video-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice.

DEVICE

Indwelling pleural catheter (with talc pleurodesis if suitable)

Once the indwelling pleural catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. At review in clinic on day 14, the participant will be assessed for spontaneous pleurodesis (\<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate.

Sponsors & Collaborators

• Sir Charles Gairdner Hospital

  collaborator OTHER

• Fiona Stanley Hospital

  collaborator OTHER

• The Sutherland and St George Hospitals, Australia

  collaborator UNKNOWN

• Hollywood Private Hospital, Australia

  collaborator UNKNOWN

• Wellington Hospital

  collaborator OTHER_GOV

• Northern Hospital, Australia

  collaborator OTHER

• Concord Hospital

  collaborator OTHER

• Royal Adelaide Hospital

  collaborator OTHER

• St John of God Midland Hospital, Australia

  collaborator UNKNOWN

• St John of God Murdoch Hospital, Australia

  collaborator UNKNOWN

• Westmead Hospital, Australia

  collaborator UNKNOWN

• St Vincent's Hospital Melbourne

  collaborator OTHER

• The Prince Charles Hospital

  collaborator OTHER_GOV

• Sunshine Coast Hospital and Health Service

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Toronto General Hospital

  collaborator OTHER

• Universiti Kebangsaan Malaysia Medical Centre

  collaborator OTHER

• Hospital Queen Elizabeth, Malaysia

  collaborator OTHER_GOV

• Johns Hopkins University

  collaborator OTHER

• John Hunter Hospital

  collaborator OTHER_GOV

• Wesley Hospital, Australia

  collaborator UNKNOWN

• Auckland City Hospital

  collaborator OTHER_GOV

• Vanderbilt University Medical Center

  collaborator OTHER

• The University of Western Australia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-29

Primary Completion

2025-08-07

Completion

2025-08-07

Countries

• Australia

Study Locations