Thyroidectomy Clinical Trial
Official title:
Phase 1 Study of Electrical Impedance Spectroscopy in Thyroid and Parathyroid Surgery
Parathyroid glands are involved in calcium metabolism and their damage during neck surgery
results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels;
this is associated with significant short and long term morbidity. There are four parathyroid
glands in the neck which can vary in size and location. They can be mistaken for lymph nodes,
fat or thyroid nodules. A normal parathyroid gland is the size of a small pea and is often
difficult to recognize during surgery; making it susceptible to inadvertent injury or
removal.
Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate
identification of parathyroid tissue during surgery reduces the likelihood of
hypoparathyroidism. However, this complication is still common. Research exploring the use of
intraoperative technologies to enable early identification and preservation of normal
parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one
such technology. ZedScanTM is a handheld device that measures electrical impedance of
tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening.
The device has a CE mark for this purpose and is safe to use in humans. We have already
demonstrated that electrical impedance spectroscopy can detect differences in cellular
structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate the
feasibility of using this technology (ZedScanTM) in humans. This has potential to be used in
thyroid and parathyroid surgery to differentiate parathyroid glands from other structures;
thereby decreasing their damage and the risk of post surgical hypothyroidism.
Patients undergoing thyroid and/or parathyroid surgery will be included. Both these groups
are being included as identification of thyroid and/or PGs are a routine part of these
operations and will provide EI measurements from both normal and abnormal parathyroid and
thyroid tissues. There is potential for EIS to be useful in all of the above procedures.
Patients will be identified at Endocrine Surgery outpatient clinics at the Royal Hallamshire
Hospital, Sheffield Teaching Hospitals. They will be invited to take part in the study during
their appointment and if interested in taking part will be given more information including a
participant information sheet. The patient will then be approached again either at their
preassessment clinic appointment or on the day of surgery to gain written consent.
Participants will be followed up in outpatient clinic as per routine care. No extra visits to
hospital are required to take part in the study.
At any of the above procedures (usually carried out under general anaesthesia), the thyroid
and/or parathyroid gland(s) in the central compartment of the neck are exposed and mobilised
prior to excision. During the procedure and prior to devascularisation and excision of the
glands, the handheld ZedScanTM will be used to take in vivo measurements of thyroid,
parathyroid, adipose tissue, lymph node and muscle. Each measurement will be performed at 14
different frequencies (ranging from 76 to 625000 Hz) in around 20 milliseconds. The
measurement will be repeated soon after excision of the appropriate structures to enable ex
vivo readings. The temperature of the patient at the time of the in vivo measurements will be
recorded by the anaesthetist and the temperature of the specimen at the time of the ex vivo
measurements will also be recorded. Care will be taken to apply the same amount of pressure
to each tissue type. Any extra readings will be clearly documented in the CRF.
A photograph of the operating field may be taken for reference when analysing the
measurements. After taking the measurements, the data is downloaded to a laptop computer and
transformed into a measure of mean EI and SD at each frequency.
Histology results of specimens excised will be reviewed along with the patient's
postoperative calcium levels from the hospital reporting system. The patient's follow up
outpatient clinic appointment notes will also be reviewed for symptoms and management of
postoperative low calcium
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