RecruitingNAINTERVENTIONAL

Oxford Pleural Embolisation Trial

This study, called the Oxford Pleural Embolisation Trial (OxPET), is investigating a technique to reduce a common side effect of lung cancer treatment called thermal ablation. Thermal ablation uses heat or cold to destroy lung tumours. A frequent problem after this procedure is a 'collapsed lung' (pneumothorax), where air leaks from the lung, often requiring a drain and a longer hospital stay. Researchers are testing if injecting a patient's own blood around the lung, known as a pleural blood patch, can seal these tiny air leaks. They want to see if this reduces the need for drains, shortens hospital stays, and makes recovery smoother for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Oxford University Hospitals NHS Trust

Enrolment target

106

Start

24 Nov 2024

Estimated completion

01 Sep 2027

Lung Cancer Lung Metastases

What is this study about?

This research is looking into a way to make a common lung cancer treatment, called thermal ablation, even safer and easier for patients. Thermal ablation is a procedure where a doctor carefully inserts a needle-like tool into a lung tumour, guided by imaging, to destroy it using heat (radiofrequency or microwave) or cold (cryotherapy). It's a key treatment for some lung cancers and can be really effective.

However, a common side effect of this procedure is a 'collapsed lung', or pneumothorax, which happens when the lung is accidentally punctured, allowing air to leak out. If this air leak is significant, patients often need a chest drain inserted to help the lung re-inflate. This drain can cause pain, limit movement, increase the risk of infection, and mean a much longer stay in hospital. This study aims to see if a technique called 'pleural blood patch' (PBP) can reduce these problems. PBP involves taking a small amount of the patient's own blood and injecting it carefully around the lung at the end of the ablation procedure to help seal any potential air leaks.

Previous research with lung biopsies (where a small sample of lung tissue is taken) has shown that using a patient's own blood in this way can significantly reduce the risk of a collapsed lung and the need for a drain. This Oxford study wants to see if the same protective effect happens after thermal ablation, which involves a slightly different procedure. If successful, this simple addition to the treatment could mean fewer drains, less pain, quicker recovery, and potentially allow patients to go home the same day rather than staying overnight, which would be a big benefit for patients and the NHS.

Key takeaways

This study evaluates a simple approach to reduce side effects of lung cancer ablation.
It tests if a patient's own blood can prevent collapsed lungs after treatment.
Potential benefits include fewer chest drains and quicker recovery.
Participation involves being randomly assigned to standard care or standard care plus the blood patch.
The study aims to make lung ablation safer and potentially allow for day-case procedures.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and already planned to have a lung ablation procedure as part of your cancer treatment. It's really important that you are also willing and able to understand the study details and give your consent to take part.

There are a few reasons why you might not be able to join the study. If for any reason your medical team decides you can't have the lung ablation procedure after all, then you wouldn't be able to participate. Also, if you have three or more separate lung lesions (areas of cancer) that need to be treated in the same ablation session, you wouldn't be eligible for this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I an adult (18 or over)?
Am I already scheduled to have a lung ablation procedure?
Do I understand what the study involves and am I willing to take part?
Do I have fewer than three cancer lesions that need treatment in the same ablation session?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive their lung ablation treatment as usual. The other group will receive their lung ablation treatment plus the 'pleural blood patch' (PBP) procedure, where a small amount of your own blood is injected around the lung to help seal any potential air leaks. The PBP procedure is done at the same time as your ablation and doesn't involve extra appointments before or after for this specific intervention.

Throughout the study, doctors will monitor whether you need a chest drain, how much air might be leaking from your lung, and how long you stay in hospital. You'll also be asked about your pain levels using a simple questionnaire. There are no additional medications compared to your standard care. The total duration of your participation in terms of active treatment and immediate follow-up will align with your scheduled ablation procedure and subsequent recovery period, typically until hospital discharge.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduced chance of needing a chest drain and potentially a quicker recovery and shorter hospital stay if you are in the group receiving the pleural blood patch. However, there's no guarantee the treatment will work for everyone, and it's important to remember that all medical procedures carry some risks, including side effects from the ablation itself, infection, or pain. The pleural blood patch technique is generally considered safe with few additional risks. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is thermal ablation?

Thermal ablation is a treatment for lung cancer that uses heat or cold to destroy a tumour, without needing major surgery.

What is a 'collapsed lung'?

A 'collapsed lung', or pneumothorax, happens when air leaks from the lung into the space around it, which can cause breathing problems and often requires a drain.

What is a pleural blood patch?

It's a technique where a small amount of your own blood is injected around the lung after an ablation to help seal potential air leaks and prevent a collapsed lung.

Will I know if I'm getting the blood patch?

No, you will be randomly assigned to either receive the blood patch or not, like drawing lots, to ensure a fair comparison for the study.

How long will I be in hospital?

One of the goals of the study is to see if the blood patch can help shorten hospital stays, potentially allowing for same-day discharge for some patients, but this will vary.

How to find out more

Dr Yan-Lin Li Consultant Interventional Radiologist, EBIR FRCR FHKAM

yan-lin.li@ouh.nhs.uk 44 1865 235746 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.