Does near infrared fluorescence imaging reduce the risk of hypoparathyroidism after thyroid surgery?

Not Applicable

• Conditions: Surgery; ear Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH) after Thyroid Surgery

• Registration Number: ISRCTN59074092
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Last Update Posted: 22 April 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Aged >=18 years
2. Able to provide written informed consent
3. Due to undergo total or completion thyroidectomy with or without central neck dissection (indications for surgery may include Graves’ disease, suspected or confirmed thyroid cancer, and goitre with compressive effects).
4. ASA <=3
5. Able and willing to comply with the terms of the protocol including participant completed questionnaires

Exclusion Criteria

Current exclusion criteria as of 19/06/2023:

1. Patients undergoing concomitant parathyroid or thoracic surgery
2. Patients undergoing re-operative thyroid surgery (except completion thyroidectomy after previous contralateral lobectomy)
3. Documented hypo or hypercalcaemia within the last 3 months prior to planned date of thyroid surgery, defined as adjusted calcium <2.1 mmol/L or >2.6 mmol/L
4. Pregnancy
5. Known allergy to ICG, iodine or iodine dyes.
6. Patients with significant renal impairment (defined as eGFR < 40ml/min/1.73m² (or a serum creatinine value >10% of upper value for normal institutional limits if eGFR is not performed locally)
7. Taken calcium or active vitamin D supplements (such as alfacalcidol or calcitrol) in the 2 weeks prior to randomisation or due to receive prophylactic treatment with calcium and/or vitamin D supplements peri-operatively

____

Previous exclusion criteria:

1. Patients undergoing concomitant parathyroid or thoracic surgery
2. Patients undergoing re-operative thyroid surgery (except completion thyroidectomy after previous contralateral lobectomy)
3. Documented hypo or hypercalcaemia within the last 3 months prior to planned date of thyroid surgery
4. Pregnancy
5. Known allergy to ICG, iodine or iodine dyes.
6. Patients with significant renal impairment (defined as eGFR < 40ml/min/1.73m² (or a serum creatinine value >10% of upper value for normal institutional limits if eGFR is not performed locally)
7. Hepatic dysfunction, defined as bilirubin outside of institutional limits and/or ALT/AST >2.5 x institutional upper limit of normal.
8. Taken calcium or active vitamin D supplements (such as alfacalcidol or calcitrol) in the 2 weeks prior to randomisation or due to receive prophylactic treatment with calcium and/or vitamin D supplements peri-operatively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase II primary outcome: Transient hypocalcaemia, defined as any adjusted calcium of <2.1 mmol/L on the day after surgery measured using calcium and serum albumin blood values from a blood test<br>Phase III primary outcome: Incidence of post-surgical hypoparathyroidism (PoSH) at 6 months post-surgery. In accordance with the national British Association of Endocrine and Thyroid Surgeons (BAETS) definition, PoSH is defined as the need for calcium and/or vitamin D supplements to treat symptoms or maintain adjusted calcium in the low normal range (between 2.1 and 2.3 mmol/L) at 6 months after surgery, measured using medical records