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

NARecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

May 29, 2018

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Malignant Pleural EffusionRespiratory DiseaseCancer
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.

Trial Locations (1)

6009

RECRUITING

Institute for Respiratory Health, Nedlands

All Listed Sponsors
collaborator

Sir Charles Gairdner Hospital

OTHER

collaborator

Fiona Stanley Hospital

OTHER

collaborator

The Sutherland and St George Hospitals, Australia

UNKNOWN

collaborator

Hollywood Private Hospital, Australia

UNKNOWN

collaborator

Wellington Hospital

OTHER_GOV

collaborator

Northern Hospital, Australia

OTHER

collaborator

Concord Hospital

OTHER

collaborator

Royal Adelaide Hospital, Australia

UNKNOWN

collaborator

St John of God Midland Hospital, Australia

UNKNOWN

collaborator

St John of God Murdoch Hospital, Australia

UNKNOWN

collaborator

Westmead Hospital, Australia

UNKNOWN

collaborator

St Vincent's Hospital Melbourne

OTHER

collaborator

The Prince Charles Hospital

OTHER_GOV

collaborator

Sunshine Coast Hospital and Health Service

OTHER

collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

collaborator

Toronto General Hospital

OTHER

collaborator

Universiti Kebangsaan Malaysia Medical Centre

OTHER

collaborator

Hospital Queen Elizabeth, Malaysia

OTHER_GOV

collaborator

Johns Hopkins University

OTHER

collaborator

John Hunter Hospital

OTHER_GOV

collaborator

Wesley Hospital, Australia

UNKNOWN

collaborator

Auckland City Hospital

OTHER_GOV

collaborator

Vanderbilt University Medical Center

OTHER

lead

The University of Western Australia

OTHER

NCT04322136 - AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion | Biotech Hunter | Biotech Hunter