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EIS in Thyroid and Parathyroid Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901873
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Thyroidectomy Parathyroid Diseases Device: Electrical Impedance Spectroscopy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1 Study of Electrical Impedance Spectroscopy in Thyroid and Parathyroid Surgery
Actual Study Start Date : June 27, 2016
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : June 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Active Comparator: Thyroid surgery
Electrical Impedance Spectroscopy in Thyroid surgery
Device: Electrical Impedance Spectroscopy
Active Comparator: Parathyroid surgery
Electrical Impedance Spectroscopy in parathyroid surgery
Device: Electrical Impedance Spectroscopy



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • - 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901873


Locations
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United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02901873    
Other Study ID Numbers: STH18736
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs