IOPTH in TT

• Research type

  Research Study

• Full title

  Prognostic value of intraoperative parathormone (IOPTH) measurements in predicting hypocalcaemia after total thyroidectomy (TT). Clinical validity, prospective, single arm, observational study.

• IRAS ID

  360740

• Contact name

  Tom R Kurzawinski

• Contact email

  tom.kurzawinski@nhs.net

• Sponsor organisation

  University College London Hospital Trust

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Hypocalcaemia (low blood calcium) is the commonest complication in patients undergoing total thyroidectomies and can be temporary, if it lasts for up to 3 months (30-40%) or is considered to be permanent when it is still present 3-12 months after surgery (5-10%). Hypocalcaemia is caused by the damage to parathyroid glands which could be the result of their inadvertent removal or damage to their blood supply during surgery. (Gray et al. 2021, Philip et al.2024)
  Parathyroid glands secrete parathormone (PTH), a hormone responsible for regulating calcium concentration in the blood. Biological half-life of PTH is 5 minutes and therefore it disappears from the circulating blood very quickly if parathyroids are damaged. Developing hypocalcaemia, which is the consequence of damaging parathyroids, is however a much slower process and can take 12 to 24 hours. Therefore, relying on calcium measurement to diagnose hypocalcaemia and decide whether calcium supplementation is required takes longer and patients need to stay in the hospital to have their calcium assessed. This results in prolonged hospitalisation significantly adding to the cost of care and pressure on inpatient’s beds. (Daskalaki et al. 2022, Edafe 2014)

  Treatment of hypocalcaemia after thyroid surgery involves either intravenous infusion of calcium, if symptoms are very severe, or oral calcium and Vitamin D (alfa calcidol) supplementation. Timely decision about the need for calcium and Vitamin D supplementation prevents unpleasant and sometimes dangerous symptoms of low calcium and facilitates early discharge. (Shawky et al. 2019, Nagel et al. 2022)

  Measuring PTH after the operation is known to predict either normocalcaemia or hypocalcaemia with high degree of accuracy. (Yuan et al. 2021, Nagel et al. 2022, Edafe et al. 2014) Unmeasurable or abnormally low PTH concentration are associated with low postoperative calcium and indicate need for supplementation of calcium and Vitamin D. Measurable and within range PTH levels after surgery predict that calcium will be normal, patient can be discharged earlier with no additional treatment with calcium necessary.

  Currently, PTH measurements after thyroid surgery are done in the main laboratory and this introduces a delay in obtaining results, sometimes PTH results are not available for 24 to 48 hours. Novel NBCL Analyzer is designed to measure PTH concentration very quickly in 5 minutes and has been used very successfully in parathyroid surgery. It measures PTH in whole blood (no centrifuging), is fully automated and uses a single cartridge and therefore is very simple and can be performed by non laboratory staff i.e. doctors and nurses). (Kurzawinski et al. 2024

  We propose to validate PTH measurements on NBCL Analyser during perioperative period and assess its accuracy in predicting postoperative hypocalcaemia. Patients undergoing total thyroidectomies will be asked to participate in the study and sign Consent Form.

  Blood samples during surgery will be taken and PTH levels measured:
  1. When patients are already under GA but operation has not started yet
  2. Halfway through the operation after the dissection of first thyroid lobe
  3. At the end of surgery after skin closure

  On the morning of the first day after surgery patients will have calcium and PTH measured on the main UCLH laboratory platform (standard care) and a decision about need for calcium supplementation will be based on these values.

  Outcome of the study will be determined by the ability of intraoperative PTH measurements to predict hypocalcaemia and abnormal levels of PTH and need for calcium supplementation during hospital stay and on discharge.
  

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  25/NW/0380

• Date of REC Opinion

  16 Dec 2025

• REC opinion

  Favourable Opinion