Thyroid Disease Clinical Trial
Official title:
The Use of Near-Infrared Fluorescence Imaging in Parathyroid Visualization During Thyroid Surgery: a Pilot Study
During surgery in which the thyroid is removed (thyroidectomy), the identification of
parathyroid glands, that should be saved, can be challenging. Therefore, there is need for
accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can
be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).
Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid
surgery will provide real-time intraoperative visualization of the parathyroid glands.
This prospective observational feasibility study aims to evaluate the feasibility of the use
of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18
years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing
total thyroidectomy are suitable for inclusion. In all patients, undergoing total
thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of
7.5 mg ICG, will be tested on feasibility and imaging characteristics.
In this study, the feasibility of the use of NIR fluorescence imaging for the identification
of the parathyroid glands during thyroid surgery will be explored.
Per-operatively: The surgery will start as usual. When the surgeon would normally search for
the parathyroid glands, 7.5 mg of ICG will be administered intravenously through the infusion
in the patients arm. An intravenous administration is chosen because of the minimal invasive
nature and results of the described earlier case series in which ICG was also administered
via peripheral infusion. Directly after that, the fluorescence system can be switched to
fluorescence mode. The surgeon will determine whether the parathyroid glands are visible now.
If needed, due to washout, a second dose of 7.5 mg of ICG can be administered. After
identification of the parathyroid glands, surgery will continue as in the standard situation,
until there is a desire to visualize the parathyroid glands again, then another dose of ICG
can be given. Time until first identification of the parathyroid glands and total surgical
time will be measured. After complete removal of the thyroid, another 7.5 mg of ICG will be
administered intravenously to visualize the vascularization of the parathyroid gland. The
intensity will be subjectively scored: 1 parathyroid black after injection of ICG, 2
partially vascularized, or 3 parathyroid is green; well vascularized. The fluorescence system
will be used to record the whole procedure. Directly after the procedure the researcher will
ask the surgeon whether he or she thinks the technique is feasible.
Postoperatively: As in standard care, after thyroid surgery, the serum calcium levels will be
determined. Low calcium levels can indicate misidentification of parathyroid glands. These
calcium levels are determined only in patients after total thyroidectomy on day 1, 2 and
after two weeks. Also TSH will be determined after two weeks as in standard care. The thyroid
specimen will be send to pathology. In the specimen, the pathologist will search for
parathyroid glands, as is standard care. Furthermore, video recordings will be analyzed,
quantifying the fluorescence signal compared to the background: measuring the Target to
Background Ratio. Also, in these video recordings the time until visualization of the
parathyroid glands will be reassessed by an independent expert.
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