NIFTy: Near Infrared Fluorescence (NIRF) Imaging to prevent Post-surgical Hypoparathyroidism (PoSH) after Thyroid Surgery (NIFTy) - A phase II/III pragmatic, multicentre randomised controlled trial

Start date: 1 October 2019
End date: 30 April 2024
Funder: National Institute for Health and Care Research (NIHR)
Value: £1,053,738.61
Partners and collaborators: Sheffield Teaching Hospitals
Primary investigator: Professor Saba Balasubramanian, Consultant Endocrine Surgeon and Honorary Professor
Co-investigators: Professor Julia Brown

Description

Aim

To determine the efficacy of near infra-red fluorescence (NIRF) imaging in reducing the risk of post-surgical hypoparathyroidism after bilateral thyroid surgery in a multi-centre randomised controlled trial comparing NIRF imaging versus standard surgery.

Background

Post-surgical hypoparathyroidism (PoSH) is an iatrogenic disease that occurs as a complication of several different procedures. Thyroidectomy is the most common predisposing operation and is performed for a range of benign and malignant conditions. The mechanisms of PoSH include devascularisation, direct damage and inadvertent removal of the parathyroid glands. PoSH has significant short and long term morbidity. In the short term, its occurrence can prolong hospital stay and is associated with multiple hospital attendances, readmission to hospital, ongoing monitoring and treatment – all significantly increasing costs of treatment. In the long term, PoSH can cause a wide range of symptoms, a ‘high burden of illness’ and a negative impact on quality of life.

Over 12,000 thyroid operations are done every year in England, a significant proportion of which involves bilateral thyroid surgery and carries a risk of this complication. The volume of thyroid surgery for both benign and malignant disease is increasing and PoSH is therefore likely to increase. Recently studies have shown promising results using a new technology, near infrared imaging (NIRF) in reducing the risk of PoSH. A significant reduction in the incidence of transient and long term hypoparathyroidism has potential to significantly reduce morbidity and costs associated with monitoring and treatment. Design: A prospective unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial comparing thyroidectomy surgery with near-infrared fluorescence (NIRF) and Indocyanine Green (ICG) against standard thyroidectomy surgery to determine the effect on 6-month post-surgical hypoparathyroidism (PoSH) in patients undergoing thyroidectomy.

The primary objective of the Phase II component is to determine whether to continue to recruit to the full Phase III sample size, or whether to conclude the trial on the basis of futility.

The primary objective of the Phase III trial is to investigate the efficacy and mechanism of a new intervention, the use of NIRF + ICG during thyroidectomy, in reducing the rate of PoSH compared to standard thyroidectomy. Trial Population: 454 adult participants, due to undergo total or completion thyroidectomy with or without central neck.