ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
This study, called ESTIM-ABL, is for people with a common type of thyroid cancer that has a low risk of spreading. We want to see if removing just the thyroid gland (total thyroidectomy) is as effective as removing the thyroid gland plus some nearby lymph nodes in the central part of the neck. This extra step is called a prophylactic central compartment neck dissection. The aim is to understand which method is better at stopping the cancer from returning, while avoiding unnecessary surgery. Participants will be randomly assigned to one of these two surgery types before their operation.
At a glance
What is this study about?
When someone is diagnosed with thyroid cancer, doctors need to decide on the best way to treat it. For a common type of low-risk thyroid cancer, doctors sometimes remove the entire thyroid gland. However, sometimes they also consider removing nearby small glands called lymph nodes in the central part of the neck at the same time. This extra step is called a 'prophylactic central compartment neck dissection' because it's done as a preventative measure, even if there's no clear sign the cancer has spread to these nodes.
This study, called ESTIM-ABL, aims to find out if removing these extra lymph nodes really makes a difference for people with low-risk thyroid cancer. The main question is: Is simply taking out the thyroid gland just as good at stopping the cancer from coming back as taking out the thyroid gland with the extra lymph nodes?
By comparing these two surgical approaches, the study hopes to help doctors make better choices about treatment. If removing just the thyroid gland is proven to be as safe and effective, it could mean fewer people need a more extensive operation, which might help reduce side effects and recovery time.
Key takeaways
- The study compares two ways to operate on low-risk thyroid cancer.
- It aims to see if removing extra lymph nodes really helps, or if it's unnecessary.
- You will be randomly assigned to one of two surgery groups.
- Participation helps improve future care for thyroid cancer patients.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you generally need to be at least 18 years old and speak French. Your thyroid cancer must be a specific type called 'papillary thyroid carcinoma' and it needs to be considered 'low-risk'. This usually means the lump in your thyroid is between 11mm and 40mm and there are no signs that the cancer has spread beyond the thyroid to other areas, especially to the lymph nodes in your neck. Doctors will check this carefully using scans and other tests.
There are also some reasons why you might not be able to join. For example, if your thyroid lump is smaller than 11mm or larger than 40mm, or if the cancer has clearly spread outside the thyroid. If you already have signs of cancer in your lymph nodes, or if you have other medical conditions that would make the surgery unsafe, you wouldn't be able to take part. Women who could become pregnant would need to use effective contraception if they receive certain treatments, like radioiodine, as part of their care after surgery.
Before you can join, you'll need to understand what the study involves and sign a consent form. You'll also need to be able to attend all the study appointments.
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 old or older?
- Do you have a specific type of low-risk thyroid cancer (papillary thyroid carcinoma)?
- Is your thyroid lump between 11mm and 40mm?
- Are there no signs the cancer has spread beyond your thyroid on initial scans?
- Do you speak and understand French?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of two surgery groups: either having just your thyroid removed, or having your thyroid removed along with some nearby lymph nodes in your neck. This decision will happen before your surgery. If there's any doubt about your cancer type, doctors might confirm it during the operation before you're assigned to a group. After your surgery, the doctors will keep a close eye on your recovery and how you're doing over time to see how effective each treatment is.
Potential risks and benefits
Locations (21)
- Gustave RoussyVerified postcodeVillejuif, France
- CHU d'AngersVerified postcodeAngers, France
- Hôpital Saint AndréVerified postcodeBordeaux, France
- Institut BergoniéVerified postcodeBordeaux, France
- Groupement Hospitalier EstVerified postcodeBron, France
- Centre François BaclesseVerified postcodeCaen, France
- Jean PerrinVerified postcodeClermont-Ferrand, France
- Centre Georges François LeclercVerified postcodeDijon, France
- CH de HaguenauVerified postcodeHaguenau, France
- CHU Lille, Hôpital Claude HuriezVerified postcodeLille, France
- CHU NimesVerified postcodeNîmes, France
- CHU de PoitiersVerified postcodePoitiers, France
Common questions
What is 'low-risk differentiated thyroid cancer'?
It's a common type of thyroid cancer that usually grows slowly and is less likely to spread aggressively.
What is a 'total thyroidectomy'?
This is an operation where a surgeon removes all of your thyroid gland.
What does 'prophylactic central compartment neck dissection' mean?
This is an extra step during surgery where a surgeon removes some lymph nodes from the central part of your neck, just in case cancer cells might be there, even if they can't be seen.
Why is this study important?
It helps doctors understand if an extra surgery step (removing lymph nodes) is truly needed for low-risk thyroid cancer, which could help avoid unnecessary operations for patients in the future.
Will I get to choose which surgery I have?
No, you will be randomly assigned to one of the two surgery groups, like drawing lots, to ensure the study results are fair and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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