Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PTeye™ parathyroid detection system.
- Who it may be relevant to
- Registry conditions: Hypocalcemia, Parathyroid, Hypoparathyroidism Post-surgical, Total Thyroidectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
Overview
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.
Detailed description
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
Interventions
- Device PTeye™ parathyroid detection system
The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
Primary outcome measures
- Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) [Time frame: 6 months]
Secondary outcome measures (6)
- Rate of inadvertent parathyroidectomy (in %) [Time frame: within 4 weeks from operation]
- Rate of parathyroid auto-transplantation (in %) [Time frame: within operation]
- Day 0 PTH [Time frame: Post-operative Day 0]
- Day 1 Post-operative serum parathyroid hormone levels (pmol/L) [Time frame: Post-operative Day 1]
- 3-month Post-operative serum parathyroid hormone levels (pmol/L) [Time frame: Post-operative 3 months]
- 6-month Post-operative serum parathyroid hormone levels (pmol/L) [Time frame: Post-operative 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Publications
- Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15:
- Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14:
- Lui DTW, Fung MMH, Lee CH, Fong CHY, Woo YC, Lang BHH. A territory-wide assessment of the incidence of persistent hypoparathyroidism after elective thyroid surgery and its impact on new fracture risk over time. Surgery. 2021 Nov;170(5):1369-1375. doi: 10.1016/j.surg.2021.05.004. Epub 2021 Jun 8. PMID 34116859
- Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. PMID 24402815
- Payne RB, Little AJ, Williams RB, Milner JR. Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J. 1973 Dec 15;4(5893):643-6. doi: 10.1136/bmj.4.5893.643. PMID 4758544
- Solorzano CC, Thomas G, Baregamian N, Mahadevan-Jansen A. Detecting the Near Infrared Autofluorescence of the Human Parathyroid: Hype or Opportunity? Ann Surg. 2020 Dec;272(6):973-985. doi: 10.1097/SLA.0000000000003700. PMID 31804401
- Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6. PMID 29122325
- Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31. PMID 30710614
Identifiers
NCT: NCT07416149 · UW-25-412