RecruitingNAINTERVENTIONAL

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

This study is exploring a new treatment for small, non-cancerous growths in the pancreas called neuroendocrine tumours (PNETs). Currently, these are often just watched, which can cause patients a lot of worry and can be expensive. The new treatment, called radiofrequency ablation (RFA), uses heat applied directly to the tumour with a special camera (echo-endoscopy) to destroy it. Early studies have shown promising results, and this new, larger study aims to make sure RFA is effective and safe for treating these specific types of PNETs. It focuses on small tumours that aren't causing symptoms and are slow-growing. Patients who take part will have the treatment and then be carefully monitored for five years to see how well it works and if there are any side effects.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Paoli-Calmettes

Enrolment target

Start

30 Mar 2021

Estimated completion

01 Apr 2031

Neuroendocrine Tumor of Pancreas (Disorder)Neuroendocrine Tumor Grade 1

What is this study about?

This research study is about a new way to treat a specific type of growth in the pancreas called a neuroendocrine tumour, or PNET for short. These are usually slow-growing, and often don't cause any problems. At the moment, doctors often keep a close eye on these tumours to see if they change. This can be a long process, which can make patients feel anxious, and it can also involve many hospital visits and tests.

The study wants to see if a treatment called radiofrequency ablation (RFA) could be a good alternative. RFA uses heat to destroy the tumour cells. This heat is delivered very precisely using a special camera inserted into the body, called an echo-endoscope. The idea is that by treating the tumour directly, it might remove the need for constant monitoring, which could improve patients' peace of mind and reduce healthcare costs.

So far, only a few small studies have looked at using RFA for these pancreatic tumours, and the results have been encouraging. This new, larger study hopes to confirm that RFA is both effective at getting rid of the tumors and safe to use, with very few side effects, especially for small, non-symptomatic PNETs. They want to make sure it's a reliable treatment option for suitable patients.

Key takeaways

This study explores a new heat-based treatment (RFA) for small pancreatic neuroendocrine tumours.
It aims to offer a less anxious alternative to just watching these tumours.
Patients would have the treatment and then be monitored for 5 years.
Only small, non-symptomatic, slow-growing tumours are included.
This is a careful study to confirm the treatment's safety and effectiveness.

Who may be eligible?

To be considered for this study, you would need to have a pancreatic tumour that is smaller than 2cm (about the size of a small pea) when seen on a scan like an MRI or CT. Importantly, doctors must have confirmed through a biopsy that it's a neuroendocrine tumour, and it must be a slow-growing type (called 'Grade 1'). The tumour shouldn't be causing any symptoms, like making hormones, and it shouldn't show up as very active on a special type of scan called a PET scan.

There are also some general health requirements. You would need to be between 18 and 80 years old and generally in good health. You'd also need to agree to take part and be covered by a healthcare insurance system. If you meet these main points, the medical team will look at other details to see if the study is right for you.

However, some people would not be able to join. This includes if you are pregnant, breastfeeding, or could become pregnant without using effective contraception. You also can't join if you have other serious medical conditions that might limit your life expectancy, or if you have severe bleeding problems. This study is also not for those whose tumour is pressing on or too close to important tubes in the pancreas (like the bile duct) or if the cancer has spread to other parts of the body.

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.

Is your pancreatic tumour less than 2cm (small)?
Has it been confirmed as a slow-growing neuroendocrine tumour (Grade 1)?
Are you between 18 and 80 years old and generally well?
Are you not pregnant, breastfeeding, or planning to become pregnant without contraception?
Is your tumour not causing any symptoms or actively spreading?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, the first step is to sign an informed consent form, making sure you understand everything involved. You would then undergo the radiofrequency ablation (RFA) treatment. This may involve one to three treatment sessions, depending on how your tumour responds. After the treatment, you will be carefully monitored for a period of five years. During this time, the study team will check how well the treatment worked, how you are doing overall, your quality of life, and if you experience any side effects or complications. This follow-up will involve regular check-ups and scans.

Potential risks and benefits

Taking part in this study could potentially offer you a new way to manage your pancreatic neuroendocrine tumour, which might be less stressful and reduce the need for constant monitoring compared to the current approach of 'watch and wait'. However, as with any medical procedure, there are potential risks, which will be fully explained by the medical team. These could include risks related to the procedure itself, or side effects from the heat treatment. You will have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting

Common questions

What exactly is a neuroendocrine tumour?

It's a type of growth that forms in special cells in the pancreas. They usually grow slowly and often don't cause any symptoms.

What does 'radiofrequency ablation' (RFA) mean?

RFA is a treatment that uses heat to destroy unwanted cells. In this study, the heat is delivered precisely to the tumour using a special long, thin tube with a camera.

Why is this study important?

This study aims to find out if RFA is a safe and effective treatment option for small, non-cancerous pancreatic tumours, which could offer patients an alternative to just watching them and worrying.

How long will I be involved in the study?

If you join, you will have the RFA treatment (possibly 1-3 sessions) and then be followed up by the study team for five years to see how you are doing.

Will this treatment make me better?

The study aims to see how effective the treatment is at getting rid of the tumour. It's a new approach being tested, so how well it works is what the researchers want to find out.

How to find out more

Jihane PAKRADOUNI

drci.up@ipc.unicancer.fr +33491223778 Official trial record

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