NIFTy: Near Infrared Fluorescence imaging to prevent post-surgical hypoparathyroidism after thyriod surgery - a phase II/III pragmatic, multi-centre rct

Project Description

Parathyroid glands are tiny glands in the neck behind the thyroid gland that control the level of calcium in the blood. More than 12,000 patients undergo thyroid surgery every year in England alone (HES dataset). A common complication of thyroid surgery is damage to or accidental removal of parathyroid glands. This causes a condition called hypoparathyroidism; this may be a temporary condition in ~25% of patients, but in up to 12% of cases, it is long-term requiring lifelong medication and care. It reduces blood parathyroid hormone and calcium levels resulting in a wide range of symptoms (such as tingling & numbness in the extremities, nausea and nocturnal cramps), longer hospital stays and requirement for frequent blood tests to monitor calcium levels & ongoing treatment. It has a significant impact on patients’ quality of life and the potential for kidney damage, accumulation of calcium in the tissues and seizures; this can be life threatening.

Recently, a new intraoperative technique using fluorescence (glow) from a dye called methylene blue (MB) has been shown in an early trial (3) to help in accurate identification and preservation of parathyroid glands during thyroid and parathyroid surgery. MB has been used in humans for over 20 years and is considered very safe at low doses. We are setting up a further study to determine if this technology will help reduce the risk and severity of hypoparathyroidism.

Aim:To find out how many patients develop short and long term parathyroid damage following the use of this technology compared to those who underwent surgery in the standard manner. The study will also determine if this new treatment will reduce hospital stay after surgery and improve quality of life for patients.