NIFTy - NIRF Imaging to prevent PoSH after thryroid surgery
Research type
Research Study
Full title
Near Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH)after Thyroid Surgery (NIFTy) - A phase II/III pragmatic, multicentre randomised controlled trial
IRAS ID
287123
Contact name
SP Balasubramanian
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN59074092
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Parathyroid glands are tiny glands in the neck behind and/or below 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. A common complication of thyroid surgery is damage to or accidental removal of parathyroid glands. This causes a condition called hypoparathyroidism, which may be temporary 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 quality of life and the potential for kidney damage, accumulation of calcium in the tissues and seizures; this can be life threatening.
A new intraoperative technique using fluorescence (glow) from a dye has been shown to help identification and preservation of parathyroid glands during thyroid and parathyroid surgery. The study will 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, and will also determine if this new treatment will reduce hospital stay after surgery and improve quality of life for patients.
The trial will initially recruit 200 patients to determine whether there is enough early evidence of efficacy to justify recruiting a larger sample of patients for definitive analysis. If there is, then we aim to recruit to a total of 454 patients from 10 hospitals.
REC name
Wales REC 5
REC reference
21/WA/0375
Date of REC Opinion
20 Jan 2022
REC opinion
Further Information Favourable Opinion