Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)-Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy: A Randomized Controlled Trial

What this Trial Is About

Post-operative hypoparathyroidism (PH) is a challenging complication following total thyroidectomy, caused by accidental removal or damage to the parathyroid glands. Researchers are evaluating whether the PTeye™ device, which uses near-infrared autofluorescence (NIRAF) technology, can help reduce PH by better identifying these glands during surgery. This prospective, single-blinded, randomized controlled trial enrolls patients undergoing total thyroidectomy at a tertiary endocrine surgery unit in Hong Kong. Participants will be randomly assigned to one of two groups: one receiving conventional total thyroidectomy and the other undergoing surgery assisted by the PTeye™ parathyroid detection system. PTeye™ uses a probe that emits laser and detects near-infrared signals in real time to identify parathyroid glands early during the operation, aiming to avoid their inadvertent removal or devascularization. During the study, participants will receive medical care as usual. Researchers will measure the rate of significant post-operative hypoparathyroidism six months after surgery, along with secondary outcomes such as rates of unintended parathyroid removal, parathyroid auto-transplantation, and parathyroid hormone levels on the day of surgery, the following day, and at three and six months post-operation. The trial starts in September 2025 and continues until December 2028.

Comparing PTeye-assisted Versus Conventional Total Thyroidectomy