Hypoparathyroidism
Conditions
Brief summary
Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. ICG was already approved in 1956 for clinical use of tissue perfusion. However, until now there is still no (parathyroid) universal standard imaging protocol for ICG-guided fluorescent surgery including quantitative evaluation. Main research question To develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with ICG including quantitative evaluation of the fluorescent signal. • Design (including population, confounders/outcomes) This will be a proof-of-concept, prospective cohort study of patients undergoing an ICG-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. The main study endpoint is quantification of the fluorescent signal of ICG stratified by the occurrence of hypoparathyroidism. Hypoparathyroidism will be defined as a decrease in PTH of >70% at the first postoperative day. Furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism. Secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, PTH, albumin) and postoperative medication use. Expected results We expect that the results of this study will lead to the development of a universal standard imaging protocol for ICG-guided fluorescent total thyroidectomy.
Interventions
ICG-NIRF was performed using the Quest Spectrum Platform 2.0. The camera lens was positioned at a fixed distance of 30 cm to the wound bed, at a perpendicular angle, with the gain set at 22.5 decibels (dB) and an exposure time of 50 milliseconds (ms). ICG was dissolved in sterile water at a concentration of 2.5 mg/mL as recommended by the manufacturer (Verdye). 1.5 mg of ICG per liter of circulating blood volume was then administered through manual bolus intravenous injection. Blood volume estimation was based on the patient's height and weight.
Sponsors
Erasmus Medical Center
Leiden University Medical Center
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A multicenter study is being conducted using standardized ICG-NIRF imaging of the parathyroid glands following total thyroidectomy. Perfusion curves are generated and analyzed postoperatively, with flow parameters being linked to postoperative parathyroid function. The study consists of two groups: the first group includes patients undergoing total thyroidectomy, where perfusion curves are compared between different patients. The second, smaller group is part of a root cause analysis, where the effects of injection speed and ICG concentration on the reproducibility of perfusion curves are evaluated by comparing curves within the same patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age >18 years 2. Patients undergoing ICG-guided total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter 3. Patients are eligible for surgery 4. Patients are mentally competent 5. Written informed consent
Exclusion criteria
1. Patients with known allergy for ICG or iodinated contrast 2. Pregnant or lactating women 3. Patients with previous neck surgery 4. Patients with dialysis dependent renal failure and kidney transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection speed | During surgery | The impact of injection speed on a parathyroid perfusion curve (slow vs fast) |
| ICG concentration | During surgery | The impact of ICG concentration on a parathyroid perfusion curve (2.5 mg/mL vs 0.5 mg/mL) |
| Camera system | During surgery | The impact of a camera system on a parathyroid perfusion curve (Quest vs SpyElite) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multicenter application | From surgery until one day post-surgery | The correlation between postoperative hypoparathyroidism and the perfusion curve in two different centers (UMCG/EMC) |
Countries
Netherlands
Outcome results
None listed