Hypocalcemia, Hypoparathyroidism Post-surgical, Parathyroid, Total Thyroidectomy
Conditions
Keywords
Thyroidectomy, calcium, hypocalcemia, post operation, hypoparathyroidism, PTeye™ parathyroid detection system
Brief summary
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
DEVICEPTeye™ 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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
The study design and sample size calculation was validated by an experienced biostatistician. Preliminary data showed rate of significant post-operative hypoparathyroidism (SPH) was 17.7% lower with PTeye use. A sample size of 89 per group will achieve 80% power to detect between-group difference of 17.7%. The calculations are based on a one-sided Z-Test with the significance level of 0.05. Allowing for a 15% loss to followup, 105 patients per arm (210 in total) will be recruited for the trial. Eligible patients will be first stratified to benign and malignant diseases, then randomly assigned at a 1:1 ratio to receive either PTeye-assisted or conventional surgery according to a pre-generated block randomization list. Allocation sequence will be concealed in sequentially numbered, opaque, sealed, and stapled envelopes. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments, just before surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) | 6 months | Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of inadvertent parathyroidectomy (in %) | within 4 weeks from operation | Rate of inadvertent parathyroidectomy (in %) |
| Rate of parathyroid auto-transplantation (in %) | within operation | Rate of parathyroid auto-transplantation (in %) |
| Day 0 PTH | Post-operative Day 0 | Day 0 Post-operative serum parathyroid hormone levels (pmol/L) |
| Day 1 Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative Day 1 | Day 1 Post-operative serum parathyroid hormone levels (pmol/L) |
| 3-month Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative 3 months | 3-month Post-operative serum parathyroid hormone levels (pmol/L) |
| 6-month Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative 6 months | 6-month Post-operative serum parathyroid hormone levels |
Countries
Hong Kong
Contacts
CONTACTMan Him, Matrix Fung, MBBS
Outcome results
None listed