thyroid disease
Conditions
Interventions
The VITOM Fluorescence exoscope will be used during surgery. and in 30 patients
simultaneously the Quest Spectrum Platform.
For this, a dose of 7.5 mg ICG will be administered intravenously at least
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female patients, aged 18 years and above • Scheduled for elective total or hemi thyroidectomy • Normal liver and renal function • No known hypersensitivity for iodine, ICG, sulfa- or penicillin allergy • Able to understand the nature of the study procedures • Willing to participate and give written informed consent
Exclusion criteria
Exclusion criteria: • Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main goal of this pilot study is to investigate the feasibility of identification of the parathyroid glands with fluorescence imaging equipment with per-operative ICG administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiography of the parathyroid glands after resection of thyroid. Quantitative measurement of fluorescence signal using Target to Background Ratio (TBR) Calcium levels postoperatively day 1 and day 2 and after two weeks after total thyroidectomy PTH levels postoperatively after two weeks after total thyroidectomy Histology: are parathyroid glands in the specimen? Subjective opinion surgeon about the usefulness of the technique Time measurement: * Time until identification of first parathyroid gland * Time until identification of all four parathyroid glands * Total operation time (time from incision till closure) Differences between the two used systems (Karl Storz and Quest Medical Imaging) Intraoperative complications due to the use of the technique | — |
Countries
Netherlands
Outcome results
None listed