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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

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE June 27, 2016
Actual Primary Completion Date June 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EIS in Thyroid and Parathyroid Surgery
Official Title  ICMJE Phase 1 Study of Electrical Impedance Spectroscopy in Thyroid and Parathyroid Surgery
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Thyroidectomy
  • Parathyroid Diseases
Intervention  ICMJE Device: Electrical Impedance Spectroscopy
Study Arms  ICMJE
  • Active Comparator: Thyroid surgery
    Electrical Impedance Spectroscopy in Thyroid surgery
    Intervention: Device: Electrical Impedance Spectroscopy
  • Active Comparator: Parathyroid surgery
    Electrical Impedance Spectroscopy in parathyroid surgery
    Intervention: Device: Electrical Impedance Spectroscopy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2018)
56
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2016)
50
Actual Study Completion Date  ICMJE June 27, 2017
Actual Primary Completion Date June 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02901873
Other Study ID Numbers  ICMJE STH18736
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP