RecruitingNAINTERVENTIONAL

A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)

This research trial is investigating a new type of robotic surgery for kidney tumours that uses advanced 3D imaging to guide the surgeon. This enhanced technique is called 3D Image-Guided Robot-Assisted Partial Nephrectomy (3D IG-RAPN). The study aims to compare this new method with the standard robotic surgery (RAPN) for removing moderate to highly complex kidney tumours. Researchers want to see if the 3D imaging improves the surgery itself, reduces complications, helps preserve kidney function in the long run, and if patients live longer. The study will involve patients with a single complex kidney tumour choosing between these two surgical approaches.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

694

Start

24 Jan 2023

Estimated completion

01 Nov 2027

Renal Tumor Renal Cancer

What is this study about?

Imagine you have a kidney tumour that needs to be removed. Standard robotic surgery (called RAPN) is a common and effective way to do this. This study is looking at an exciting new version of this surgery. It uses special 3D imaging, like a high-tech satnav for the surgeon, to make the operation even more precise. This 3D navigation creates a detailed virtual picture of the kidney and tumour that the surgeon can see during the actual operation, helping them navigate with great accuracy. The hope is that this extra guidance will lead to better results.

The main goal of this research is to compare this new 3D image-guided surgery (3D IG-RAPN) with the standard robotic surgery without the 3D guidance. Researchers will be carefully observing several things. They want to know if the 3D method causes fewer problems during or just after the operation, if it's just as effective at removing all the cancer, and if it helps protect the patient's kidney function over time. They'll also be looking at how long patients live after the surgery.

This study is important because it could lead to even safer and more effective ways to treat kidney tumours. By using this advanced technology, surgeons aim to remove the tumour as completely as possible while sparing as much healthy kidney tissue as they can. This could mean better health outcomes and quality of life for people facing kidney cancer.

Key takeaways

This study compares a new 3D image-guided robotic surgery for kidney tumours with the standard robotic approach.
It aims to see if the 3D guidance improves surgery outcomes, reduces complications, and protects kidney function.
Participants will be randomly assigned to one of the two surgical methods.
The study focuses on patients with moderate to highly complex kidney tumours.
Long-term follow-up is planned to assess patient survival and kidney health.

Who may be eligible?

To be considered for this study, you would need to be over 18 years old and have been told by your doctor that you need robotic surgery to remove a suspicious kidney tumour. Specifically, your tumour should be considered moderately or highly complex, as determined by a standard scoring system your doctor would use. The hospital where your surgery would take place must also use the specific Da Vinci® robotic system for the operation.

You would also need to be part of the French social security system or a similar health insurance plan, and you'd need to agree to take part by signing an informed consent form. This form explains all the details of the study, and your agreement means you understand what's involved.

However, there are also reasons why you might not be able to join. For example, if your doctor believes that robotic surgery isn't suitable for you for medical reasons, or if you have certain kidney problems that prevent you from having a special dye injection often used in these procedures. Also, if you have an allergy to contrast dyes (which contain iodine), you wouldn't be able to participate. Finally, some specific legal protections for certain individuals in France would also mean they couldn't be included in this trial.

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.

Are you 18 years or older?
Do you need robotic surgery for a suspicious kidney tumour?
Is your kidney tumour considered moderate or highly complex?
Are you insured under the French social security system (or similar)?
Are you not allergic to contrast dyes (often used in scans)?
Do you have no medical reasons preventing you from having robotic surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive one of two types of robotic kidney surgery: either the standard robotic surgery (RAPN) or the new 3D image-guided robotic surgery (3D IG-RAPN). This decision is made by chance, like flipping a coin, to ensure a fair comparison. The surgery itself will be performed as usual, and the research team will closely monitor your progress during and after the operation.

After your surgery, researchers will keep track of your health and recovery. This will involve regular check-ups and assessments to track any complications, see how well your kidney is working, and monitor for any signs of the tumour returning. The study also aims to understand how you feel about the surgery and your long-term health.

The specific number of follow-up visits and tests will be detailed in the informed consent form. The total duration of your participation in the study, including long-term follow-up, will also be explained to you before you agree to take part. All procedures will be carried out in high-volume urology centres that are part of the UroCCR Network.

Potential risks and benefits

Potential benefits of taking part could include receiving an innovative surgical technique that aims to improve precision and potentially lead to better outcomes for your kidney tumour. However, as with any surgery, there are potential risks, including complications during or after the operation. Researchers are carefully comparing the two surgical methods to see if the new approach reduces some of these risks or improves recovery. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (2)

University Hospital Grenoble
Verified postcode
Grenoble, France· Recruiting
university HospitalGrenoble
Verified postcode
Grenoble, France· Recruiting

Common questions

What is 'Partial Nephrectomy'?

It's a surgery to remove only the tumour from your kidney, leaving behind as much healthy kidney tissue as possible.

What does '3D image guidance' mean in surgery?

It means the surgeons use special 3D pictures, almost like a high-tech map, directly during the operation to help them see and work more precisely.

Will I know which type of surgery I'm getting?

You'll be randomly assigned to either the standard robotic surgery or the new 3D image-guided one. This helps researchers compare the two methods fairly.

What kind of kidney tumours are included?

This study is for kidney tumours that are considered moderately or highly complex, meaning they might be a bit more challenging to remove cleanly.

How long will I be followed after the surgery?

The study will track your health and kidney function for a long time after surgery to understand the long-term effects of each surgical method.

How to find out more

Jean-Luc DESCOTES, Pr

jldescotes@chu-grenoble.fr 0476767642 Official trial record

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