Near Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH) after Thyroid Surgery Surgery
Conditions
Interventions
454 patients requiring a completion or total thyroidectomy will be randomised prior to surgery to receive surgery with near-infrared fluorescence (NIRF) and Indocynanine Green (ICG) or as per standard
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 2.6 mmol/L 4. Pregnancy 5. Known allergy to ICG, iodine or iodine dyes. 6. Patients with significant renal impairment (defined as eGFR 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/06/2023: Phase III secondary outcomes: 1. Post-operative Parathyroid Hormone, measured at 1 day post-operation, 1 month postoperation and 6 months post-operation 2. Transient hypocalcaemia: measured as per the phase II primary endpoint, defined as an adjusted calcium of 2.6 mmol/L occurring within 6 months of operation measured as per the phase II primary endpoint Phase III mechanistic outcome: 10. Intra-operative decision-making measured based on the opinions of the surgeons during the operation _____ Previous secondary outcome measures: Phase III secondary outcomes: 1. Transient hypocalcaemia: measured as per the phase II primary endpoint, defined as an adjusted calcium of 2.6 mmol/L occurring within 6 months of operation measured as per the phase II primary endpoint Phase III mechanistic outcome: 9. Intra-operative decision-making measured based on the opinions of the surgeons during the operation | — |
Countries
England, United Kingdom
Outcome results
None listed