Impact of Intraoperative Arteriography with Indocyanine Green in Preserving the Parathyroid Glands During Total Thyroidectomy With or Without Central Cervical Lymph Node Dissection. A Multicenter Prospective Randomized Trial.
This study, called a clinical trial, is investigating a new way to help protect tiny glands in your neck called parathyroid glands during thyroid surgery. These glands are very important for controlling your body's calcium levels. During the surgery, some patients will receive a special dye called indocyanine green, which helps surgeons see the blood supply to these glands better. Other patients will have the standard surgery without the dye. The main goal is to see if using this dye helps keep more of these important glands healthy. The study will also check calcium levels, how long surgery takes, and if patients develop issues with their calcium after surgery. It's a large study, involving many hospitals.
At a glance
What is this study about?
This research project is a clinical trial, which means it's a carefully planned study involving people to find better ways to prevent, screen for, diagnose, or treat diseases. In this particular trial, doctors are focusing on a common surgery called a total thyroidectomy. This is when the entire thyroid gland, located in your neck, is removed.
During thyroid surgery, there's a risk of accidentally damaging small, pea-sized glands called parathyroid glands. You usually have four of these, and they are crucial for keeping the right amount of calcium in your body. If these glands are damaged, it can lead to low calcium levels (something called hypocalcemia) and a condition called hypoparathyroidism, which might require lifelong medication.
This study is testing whether using a special green dye, called indocyanine green (ICG), during surgery can help. When injected, this dye glows under a special light, allowing surgeons to see the blood supply to the parathyroid glands more clearly. The idea is that if surgeons can see these glands and their blood supply better, they might be more successful at preserving them. Half the patients in the study will have this dye used during their surgery, and the other half will have the standard surgery without it. The main thing they want to find out is whether using the dye actually helps protect more of these important parathyroid glands.
Key takeaways
- The study investigates if a special dye helps protect parathyroid glands during thyroid surgery.
- Parathyroid glands are crucial for controlling your body's calcium levels.
- Half of the patients will receive the dye; half will have standard surgery.
- The main goal is to see if using the dye leads to more preserved parathyroid glands.
- Participation involves blood tests before and after surgery, with follow-ups for one year.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
You would be considered for this study if you are scheduled to have your entire thyroid gland removed, which is called a total thyroidectomy. Sometimes, this surgery also involves removing nearby lymph nodes in the neck.
The research team will check other details from your medical history to make sure this study is the right fit for you and that taking part would be safe.
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?
- Are you scheduled to have your entire thyroid gland removed (total thyroidectomy)?
- Are you able to attend follow-up appointments for up to one year?
- Are you comfortable with blood tests before and after surgery?
What does participation involve?
If you decide to join this study, your involvement would begin with standard tests before your surgery, like checking levels of calcium, vitamin D, and a hormone called PTH in your blood. During your thyroid surgery, you would either receive the special green dye or not, depending on which group you are randomly assigned to. The surgery itself will be performed as planned.
After your surgery, blood tests will be taken about 24 hours later to check your calcium and PTH levels. You will then have follow-up appointments and blood tests to check your PTH levels at 1, 3, 6, and 12 months after your operation. The total duration of your participation in the study, from surgery to the last follow-up, would be about one year.
Potential risks and benefits
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Common questions
What are parathyroid glands?
They are small glands in your neck, usually four of them, that control the amount of calcium in your blood. Calcium is important for strong bones, healthy nerves, and muscles.
Why is protecting them during thyroid surgery important?
If these glands are damaged or removed during thyroid surgery, your calcium levels can drop too low, which can make you feel unwell and may require special treatments or medication.
What is indocyanine green?
It's a special dye that glows under a specific light. Doctors use it to help them see blood vessels and tissues more clearly during surgery, which might help them protect the parathyroid glands.
Will I know if I receive the dye?
You will be assigned to a group randomly, but you will find out which group you were in after the surgery has taken place. This helps make the study fair.
What is 'hypoparathyroidism'?
This is a condition where your parathyroid glands don't produce enough of their hormone, leading to low calcium levels in your blood.
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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