Croft Julie, Ainsworth Gemma, Corrigan Neil, Gordon Katie, Perry Anna, Twiddy Maureen, Strachan Mark, Wadsley Jonathan, Mehanna Hisham, Sharma Neil, Glenister Elizabeth, Stocken Deborah D, Balasubramanian Sabapathy Prakash P
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Institute of Clinical and Applied Health Research, University of Hull, Hull, UK.
BMJ Open. 2025 Jan 30;15(1):e092422. doi: 10.1136/bmjopen-2024-092422.
Postsurgical hypoparathyroidism (PoSH) is an iatrogenic condition that occurs as a complication of several different procedures with thyroid surgery being the most common. PoSH has significant short- and long-term morbidities. The volume of thyroid surgery is increasing, and PoSH is therefore likely to increase. Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.
NIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. The trial incorporates a process evaluation (IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up framework) 2a) to inform the trial protocol, a phase II (IDEAL 2b) analysis using a surrogate primary outcome of 1 day transient hypocalcaemia to determine early futility and phase III (IDEAL 3) assessment of the primary outcome of PoSH at 6 months after surgery. 454 participants will be randomised on a 1:1 basis to evaluate thyroid surgery with NIRF and indocyanine green against standard thyroid surgery in reducing PoSH at 6 months after surgery, with the phase II analysis occurring once data are available for 200 participants. Analysis in both phases will be using multilevel logistic regression incorporating random effects with respect to surgeon and adjusting for minimisation factors. Phase III secondary outcomes include protracted hypoparathyroidism, hypercalcaemia, complications, length of stay, readmissions and patient reported quality of life using the Short Form 36 Health Survey Questionnaire and Hypoparathyroid Patient Questionnaire instruments.
NIFTy is funded by National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme (Grant Ref: 17/11/27) and approved by a Research Ethics Committee (reference: 21/WA/0375) and Health Research Authority (HRA). Trial results will be disseminated through conference presentations, peer-reviewed publication and through relevant patient groups.
ISRCTN59074092.
术后甲状旁腺功能减退（PoSH）是一种医源性疾病，是多种不同手术的并发症，其中甲状腺手术最为常见。PoSH具有显著的短期和长期发病率。甲状腺手术的数量在增加，因此PoSH可能也会增加。一些研究表明，使用近红外荧光（NIRF）成像在降低PoSH风险方面取得了有前景的结果，这有可能显著降低与监测和治疗相关的发病率和成本。
NIFTy是一项针对接受全甲状腺切除术或甲状腺次全切除术患者的非盲、平行组、多中心、无缝II/III期随机对照试验。该试验纳入了一项过程评估（IDEAL（理念、开发、探索、评估和长期随访框架）2a）以指导试验方案，一项II期（IDEAL 2b）分析，使用1天短暂性低钙血症这一替代主要结局来确定早期无效性，以及III期（IDEAL 3）对术后6个月PoSH主要结局的评估。454名参与者将按1:1随机分组，以评估使用NIRF和吲哚菁绿的甲状腺手术与标准甲状腺手术相比，在降低术后6个月PoSH方面的效果，II期分析将在有200名参与者的数据可用时进行。两个阶段的分析都将使用多级逻辑回归，纳入针对外科医生的随机效应并调整最小化因素。III期次要结局包括持续性甲状旁腺功能减退、高钙血症、并发症、住院时间、再入院情况以及使用简短36健康调查问卷和甲状旁腺功能减退患者调查问卷工具评估的患者报告的生活质量。
NIFTy由英国国家卫生与保健研究所疗效与机制评估计划资助（资助编号：17/11/27），并获得研究伦理委员会（参考编号：21/WA/0375）和健康研究局（HRA）批准。试验结果将通过会议报告、同行评审出版物以及相关患者群体进行传播。
ISRCTN59074092。
