Not yet recruitingNAINTERVENTIONAL

Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism

This study aims to find the best way to help surgeons during operations for overactive parathyroid glands. This condition, called hyperparathyroidism, can happen in people with long-term kidney disease. Surgeons sometimes use a test called Intraoperative Parathyroid Hormone (IOPTH) monitoring during the operation. This test measures a hormone called PTH to help them know if they've removed enough of the overactive glands. This study is a trial to see if it's possible to do a bigger study later on, which would compare different ways of using this monitoring. It wants to find out if using IOPTH monitoring, and which specific method, can help improve surgery outcomes and people's quality of life.

At a glance

Status

Not yet recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Jun 2026

Secondary Hyperparathyroidism Tertiary Hyperparathyroidism

What is this study about?

If you have long-term kidney disease, sometimes your parathyroid glands (small glands in your neck that control calcium levels) can become overactive. This is called hyperparathyroidism. In some cases, medication doesn't help enough, and surgery is needed to remove some of these overactive glands. This surgery can be tricky, and sometimes not all the problem glands are found and removed, meaning symptoms might not improve as much as hoped.

Doctors often use a special test during surgery called Intraoperative Parathyroid Hormone (IOPTH) monitoring. This test measures the level of a hormone (PTH) in your blood during the operation. Because this hormone's levels drop quickly once overactive glands are removed, the test can give surgeons a real-time idea of whether they've removed enough. However, there isn't a clear agreement on the best way to use this test for people with hyperparathyroidism related to kidney disease.

This study is a first step, a 'pilot' trial. It's designed to see if it's possible to do a much larger study in the future. The main goal is to find out if it's practical to compare different ways of using IOPTH monitoring during surgery. Participants will be put into different groups: some will have their surgery guided by one of four specific ways of using the IOPTH test, while others will have surgery without IOPTH guiding it. The study also wants to see if using IOPTH helps people feel better and improves their quality of life. All participants will be asked to complete questionnaires about their well-being and thinking, and have blood tests.

Key takeaways

The study aims to improve surgery for overactive parathyroid glands caused by kidney disease.
It's testing different ways of using a monitoring tool during surgery called IOPTH.
This is a pilot study, meaning it's a first step to see if a bigger study is possible.
Participants will be randomly assigned to different groups.
The study also looks at how surgery affects your quality of life.
All treatment decisions will be made by your medical team.

Who may be eligible?

This study is looking for adults aged 18 or older who are planning to have parathyroid surgery. This surgery might involve removing part or all of their parathyroid glands, sometimes with a related procedure.

You might be suitable if you have hyperparathyroidism that's linked to chronic kidney disease (this is called secondary or tertiary hyperparathyroidism), or if your hyperparathyroidism has come back after a previous surgery.

However, you cannot take part if you are pregnant or breastfeeding, if you've already had parathyroid surgery before, or if your surgery is for a different type of hyperparathyroidism called 'primary hyperparathyroidism.' You also can’t participate if you're having a very specific type of keyhole surgery for your parathyroid glands, or if you're unable to provide written permission to join the study or attend follow-up 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?
Are you having surgery for hyperparathyroidism caused by kidney disease?
Have you *not* had parathyroid surgery before (if currently pregnant/breastfeeding)?
Are you able to agree to take part in the study and attend follow-up visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of five groups. Four of these groups will have their surgery guided by different timings of the IOPTH monitoring test, while the fifth group will have surgery without IOPTH guiding it. You won't know which group you're in, and in some cases, neither will your doctors.

Before, during, and after your surgery, you will be asked to complete some questionnaires about your quality of life and your thinking abilities. You will also have blood tests taken at various times during the study period. The exact number of visits and tests will be explained by the study team, but they are all part of seeing how well the different surgical approaches work and how you feel over time. The total duration of your participation will be discussed with you.

Potential risks and benefits

Taking part in a study like this may not directly benefit you, but the information learned could help future patients with similar conditions. There are no additional risks beyond those normally associated with parathyroid surgery and routine blood tests. The study involves randomly assigning you to a group, which means you won't choose which method of monitoring guides your surgery. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

St Joseph's Hospital
Verified postcode
Hamilton, Canada

Common questions

What are parathyroid glands?

These are four small glands in your neck, near your voice box. They make a hormone called PTH, which helps control the calcium levels in your blood.

What is hyperparathyroidism?

This is when your parathyroid glands make too much PTH, leading to high calcium levels in your blood. When it's linked to kidney disease, it's called secondary or tertiary hyperparathyroidism.

What is IOPTH monitoring?

IOPTH stands for Intraoperative Parathyroid Hormone. It's a blood test done during surgery to measure PTH levels. It helps surgeons know if they've removed enough of the overactive glands.

Will I know which group I'm in?

No, you won't know which specific group you're assigned to. This is done to make the study results fair and unbiased.

Is this study safe?

The study itself doesn't add new risks beyond what's expected for parathyroid surgery and standard blood tests. Your safety will be closely monitored throughout.

How to find out more

Phillip Staibano, MD, MSc

phillip.staibano@medportal.ca 905-929-1992 Official trial record

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