ISRCTN59074092进行中（未招募）未知
ear Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH) after Thyroid Surgery (NIFTy) - A phase II/III pragmatic, multicentre randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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