ThyroidectomyNCT02901873
EIS in Thyroid and Parathyroid Surgery
A study testing Electrical Impedance Spectroscopy in people with Thyroidectomy and Parathyroid Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Parathyroid Diseases
- What is being tested?
- Electrical Impedance Spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2016to 27 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (18 years and over) undergoing thyroid and/or parathyroid surgery in Sheffield Teaching Hospitals NHS Foundation Trust (STH) will be eligible for inclusion in this study.
Who cannot join
- - Patients undergoing thyroglossal cyst surgery, re-do procedures only involving resection of lymph nodes
- Patients unable to understand spoken and written English
- Patients unable to give adequate informed consent
- Patients with a positive pre-operative pregnancy test
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
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.
Read the detailed description
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
- Conditions
- Thyroidectomy, Parathyroid Diseases
- Being tested
- Electrical Impedance Spectroscopy
- Medical subject headings
- Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance SpectroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Thyroid surgery | Active comparator | Electrical Impedance Spectroscopy in Thyroid surgery Receives: Device: Electrical Impedance Spectroscopy |
| Parathyroid surgery | Active comparator | Electrical Impedance Spectroscopy in parathyroid surgery Receives: Device: Electrical Impedance Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
generation of electrical impedance spectral curves (EI across the range of frequencies) for thyroid, parathyroid, muscle, lymph nodes and adipose tissues
Measured: single surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start27 Jun 2016
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901873
- Sponsor's protocol ID
- STH18736
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2016
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hillary SL, Brown BH, Brown NJ, Balasubramanian SP. Use of Electrical Impedance Spectroscopy for Intraoperative Tissue Differentiation During Thyroid and Parathyroid Surgery. World J Surg. 2020 Feb;44(2):479-485. doi: 10.1007/s00268-019-05169-7.
PubMed 31511942
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Electrical Impedance Spectroscopy in Thyroid and Parathyroid Surgery
- ClinicalTrials.gov ID
- NCT02901873
- Acronym / sponsor ID
- STH18736
- Conditions
- Thyroidectomy, Parathyroid Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid surgery | Active comparator | Device: Electrical Impedance SpectroscopyElectrical Impedance Spectroscopy in Thyroid surgery |
| Parathyroid surgery | Active comparator | Device: Electrical Impedance SpectroscopyElectrical Impedance Spectroscopy in parathyroid surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18 years and over) undergoing thyroid and/or parathyroid surgery in Sheffield Teaching Hospitals NHS Foundation Trust (STH) will be eligible for inclusion in this study.
Key exclusion criteria (4 listed)
- - Patients undergoing thyroglossal cyst surgery, re-do procedures only involving resection of lymph nodes
- Patients unable to understand spoken and written English
- Patients unable to give adequate informed consent
- Patients with a positive pre-operative pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance Spectroscopy | Device | Parathyroid surgery, Thyroid surgery |
Primary outcome
generation of electrical impedance spectral curves (EI across the range of frequencies) for thyroid, parathyroid, muscle, lymph nodes and adipose tissues
Time frame: single surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 31511942Hillary SL, Brown BH, Brown NJ, Balasubramanian SP. Use of Electrical Impedance Spectroscopy for Intraoperative Tissue Differentiation During Thyroid and Parathyroid Surgery. World J Surg. 2020 Feb;44(2):479-485. doi: 10.1007/s00268-019-05169-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Spectroscopy in people with Thyroidectomy and Parathyroid Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
generation of electrical impedance spectral curves (EI across the range of frequencies) for thyroid, parathyroid, muscle, lymph nodes and adipose tissues (time frame: single surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.