Using PTeye to help protect parathyroid glands during total thyroidectomy
Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
This trial will test whether using the handheld PTeye device during total thyroidectomy in adults reduces the chance of low blood calcium after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07416149 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-blinded, randomized trial at a tertiary endocrine surgery unit in Hong Kong comparing conventional total thyroidectomy with PTeye-assisted surgery. PTeye is a probe-based near-infrared autofluorescence device used early in the operation to identify parathyroid glands by a quick touch of the probe. Consecutive adults undergoing total or completion thyroidectomy with normal preoperative calcium are randomized to PTeye-assisted or conventional surgery and receive usual postoperative care. The study tracks postoperative calcium and parathyroid function to see if PTeye reduces rates of transient and permanent hypoparathyroidism.
Who should consider this trial
Good fit: Adults (≥18 years) undergoing total or completion total thyroidectomy with normal preoperative adjusted calcium and not already taking calcium or vitamin D supplements are ideal candidates.
Not a fit: Patients with pre-existing parathyroid disease, untreated hyperparathyroidism, vitamin D deficiency, severe kidney failure (eGFR <30 or on dialysis), or those already on calcium/vitamin D supplements are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, PTeye use could lower rates of temporary and permanent low calcium after thyroid removal, reducing symptoms, hospital stays, and the need for long-term supplements.
How similar studies have performed: Near-infrared autofluorescence devices have shown promise in improving parathyroid identification and reducing transient postoperative low calcium in several studies, though results vary and randomized data specific to PTeye remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥18 years of age * Undergoing total thyroidectomy, or completion total thyroidectomy * Pre-operative serum adjusted calcium levels within normal ranges Exclusion Criteria: * Patients on pre-operative calcium or vitamin D supplements * Patients with pre-operative vitamin D deficiency, defined as serum vitamin D\<30nmol/L * Patients with untreated primary or secondary hyperparathyroidism * Patient with known non-surgical hypoparathyroidism diseases * Patients with estimated glomerular filtration rate \<30ml/1.73m2/min, on dialysis, or having a history of kidney transplant
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Man Him, Matrix Fung, MBBS
- Email: mmhfung@hku.hk
- Phone: +852 2255 4232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.