Skip to content

A Multicentre Randomized Study Comparing Indwelling Pleural Catheter vs Talc Pleurodesis in Patients with a Malignant Pleural Effusion

A Multicentre Randomized Study Comparing Days in Hospital with Indwelling Pleural Catheter vs Talc Pleurodesis in Patients with a Malignant Pleural Effusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000567921
Acronym
AMPLE (Australasian Malignant PLeural Effusion trial)
Enrollment
146
Registered
2011-06-02
Start date
2012-07-02
Completion date
2014-10-16
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a multicentre randomized clinical trial aiming to evaluate the potential benefits of employing indwelling small-bore pleural catheters (IPCs) as first-line management of malignant pleural effusion, especially in reducing the need of inpatient hospital care for these patients. The study also evaluates the adverse event rates, health costs and acceptability of this new management option to patients and clinicians. Who is it for? You may be eligible for this study if you are over 18 years of age and have been diagnosed with a Symptomatic Malignant Pleural Effusion Trial Details: Participants in this study will be randomized to one of two treatment arms: either Indwelling Pleural Catheter (IPC) or Talc Pleurodesis. IPC involves a soft, flexible, silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues, administered under light sedation and local anaesthesia - often in a Day Procedure Unit with you being discharged home after just a few hours. The insertion of the catheter will allow simple, painless drainage of effusions which may end up with you needing to visit hospital less often. They are designed to remain in your chest for the rest of your life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment in keeping the pleural space dry). Talc pleurodesis is a conventional, inpatient procedure performed at the bedside. It takes an average of 6 days in hospital. A small bore chest drain is inserted, the fluid is completely drained away, and then talc is injected into the pleural space. Pleurodesis has a 60-80% chance of successfully preventing the need for further pleural drainage.

Interventions

Indwelling Pleural Catheter (IPC): A soft flexible silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues. It is anchored by a cuff in the subcutaneous segment into which fibroblasts grow. IPCs are inserted under light sedation and local anaesthesia, often in a Day Procedure Unit being discharged home after just a few hours. They allow simple, painless ambulatory drainage of effusions, averting hospital attendances. They are designed to remain in situ fo

Indwelling Pleural Catheter (IPC): A soft flexible silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues. It is anchored by a cuff in the subcutaneous segment into which fibroblasts grow. IPCs are inserted under light sedation and local anaesthesia, often in a Day Procedure Unit being discharged home after just a few hours. They allow simple, painless ambulatory drainage of effusions, averting hospital attendances. They are designed to remain in situ for the remainder of the patient's life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment keeping the pleural space dry).

Sponsors

Prof YC Gary Lee
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Symptomatic Malignant Pleural Effusion

Exclusion criteria

Age <18 years; an effusion <2cm at maximum depth; expected survival <3 months; chylothorax; previous ipsilateral lobectomy or pneumonectomy; previous attempted pleurodesis; pleural infection; leukocytopenia (<1.0x109/L); pregnant or lactating patients; uncorrectable bleeding diathesis; inability to give informed consent or comply with the protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 7, 2026