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

NCT04322136 | Completed DMC

• 2 other identifiers: AMPLE-3ACTRN12618001013257
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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 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

Respiratory Disease; Cancer; Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Need for an ipsilateral pleural intervention

  Proportion of participants requiring an ipsilateral (on the same side) pleural procedure for management of symptomatic re-accumulation of pleural fluid including surgical procedure, chest drain insertion, attempted therapeutic thoracentesis. This is a composite outcome. Data will be obtained from the participants and the hospital record.

  Participants will be followed for a maximum of 12 months or until death if sooner.

Secondary Outcomes (10)

• Need for repeat ipsilateral pleural intervention including diagnostic aspiration

  The study is for 12 months or until death if prior.

• Time to symptomatic effusion recurrence

  The study is for 12 months or until death if prior.

• All-cause hospital days

  The study is for 12 months or until death if prior.

• Degree of breathlessness

  Scores will be recorded daily for 28 days, then monthly to 6 months and 3-monthly until 12 months.

• Pain scale

  Scores will be recorded daily for 28 days, monthly to 6 months and then 3-monthly to 12 months

Study Arms (2)

IPC (with talc pleurodesis if suitable)

OTHER

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.

Device: Indwelling pleural catheter (with talc pleurodesis if suitable)

Pleurodesis via VATS

OTHER

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.

Procedure: Pleurodesis via Video-assisted thoracoscopic surgery

Interventions

Indwelling pleural catheter (with talc pleurodesis if suitable) DEVICE

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.

IPC (with talc pleurodesis if suitable)

Pleurodesis via Video-assisted thoracoscopic surgery PROCEDURE

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.

Pleurodesis via VATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18yrs;
• Unfit to undergo a surgical procedure (American Society of Anaesthesiologists Score \>/=4); 3. Pleural infection;
• \. Chylothorax; 5. Pregnancy or lactation; 6. Uncorrectable bleeding diathesis; 7. Previous ipsilateral lobectomy/pneumonectomy; 8. Inability to consent or comply with protocol.

Sponsors & Collaborators

• The University of Western Australia: lead
• Sir Charles Gairdner Hospital: collaborator
• Fiona Stanley Hospital: collaborator
• The Sutherland and St George Hospitals, Australia: collaborator
• Hollywood Private Hospital, Australia: collaborator
• Wellington Hospital: collaborator
• Northern Hospital, Australia: collaborator
• Concord Hospital: collaborator
• St John of God Midland Hospital, Australia: collaborator
• St John of God Murdoch Hospital, Australia: collaborator
• Westmead Hospital, Australia: collaborator
• St Vincent's Hospital Melbourne: collaborator
• The Prince Charles Hospital: collaborator
• Sunshine Coast Hospital and Health Service: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Toronto General Hospital: collaborator
• Universiti Kebangsaan Malaysia Medical Centre: collaborator
• Hospital Queen Elizabeth, Malaysia: collaborator
• Johns Hopkins University: collaborator
• John Hunter Hospital: collaborator
• Wesley Hospital, Australia: collaborator
• Auckland City Hospital: collaborator
• Vanderbilt University Medical Center: collaborator
• Royal Adelaide Hospital: collaborator

Study Sites (1)

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Respiration Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: May 29, 2018
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)