RecruitingACTRN12624000151538

Detection of parathyroid glands with autofluoresence during thyroid and parathyroid surgery

Assessing Efficacy of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands during Endocrine Surgery in adults


Sponsor

Alfred Health

Enrollment

100 participants

Start Date

Jan 9, 2024

Study Type

Interventional

Conditions

Summary

This study aims to assess whether use of a new near infrared imaging device (PTeye device) during thyroid and some parathyroid operations enables surgeons to confidently identify parathyroid glands. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with thyroid disease, including primary hyperparathyroidism and thyroid cancer who will be undergoing thyroid or parathyroid surgery for exploration and/or tissue removal purposes. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Both groups will undergo their scheduled thyroid/parathyroid surgery per standard procedures, however one of the groups will also have their tissue imaged using the PTeye device. It is anticipated that use of the PTeye device will add 5 minutes to the overall procedure time. It is hoped this research will determine whether use of the PTeye device enables surgeons to more confidently identify parathyroid tissue during surgery. By assisting the surgeon in correctly identifying parathyroid glands, this device may improve the quality of the operation performed on the patient.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

  • All adults (greater and equal to 18 years old) patients with thyroid disease who will be undergoing hemi or total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
  • All adults (greater and equal to 18 years old) patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.
  • All adults (greater and equal to 18 years old) patients with thyroid cancer and will be undergoing re-operative or completion thyroidectomy.
  • All adults (greater and equal to 18 years old) patients with primary, secondary or tertiary hyperparathyroidism who will be undergoing parathyroid surgery.
  • All adults (greater and equal to 18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery.

Exclusion Criteria3

  • Children and minors
  • Pregnant women
  • Patients with very high anaesthetic risks

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Interventions

BRIEF NAME: Assessing Benefits of Near Infrared Autofluorescence Detection for Identifying Parathyroid Glands during Endocrine Surgery MATERIALS USED: The intervention will evaluate whether the P

BRIEF NAME: Assessing Benefits of Near Infrared Autofluorescence Detection for Identifying Parathyroid Glands during Endocrine Surgery MATERIALS USED: The intervention will evaluate whether the PTeye (Medtronic, Santa Barbara, CA) a probe-based near infrared autofluorescence detection device that consists of a console, a handheld fibre optic probe, a foot pedal and an external power supply, can assist surgeons to identify PGs during thyroid and parathyroid operations confidently. PROCEDURE: A standard thyroid or parathyroid operation will take place and use of he PTeye will occur if the patient has been randomised to the intervention arm The handheld fibre optic probe is initially applied to the thyroid gland to record a “baseline” for the device. This will take approximately 10 seconds. The probe will subsequently be used on tissue that is thought to be parathyroid tissue. The use of the PTeye would be expected to add another 5 minutes to the operative time. WHO WILL DELIVER: Endocrine surgeons as Alfred Health TRAINING Surgeons have been provided training by the inventor of the device from Vanderbilt University, Nashville, TN. The Principal Investigator has also spent time at Vanderbilt University with a surgeon who has had the greatest experience in the use of the PTeye. MODE OF DELIVERY: The intervention will occur with an individual surgeon and patient at the time they are undergoing the relevant endocrine operation. NUMBER OF TIMES: Approximately 6 times per week, dependent on the individual surgeon’s schedule LOCATION OF INTERVENTION: Alfred Hospital operating theatres


Locations(1)

The Alfred - Melbourne

VIC, Australia

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ACTRN12624000151538