Comparing PTeye-assisted Versus Conventional Total Thyroidectomy

Официальное название

Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial

Обзор

This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.

Подробное описание

Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.

Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.

A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.

This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.

Вмешательства

• Устройство PTeye™ parathyroid detection system
  The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.

Первичные конечные точки

• Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Rate of inadvertent parathyroidectomy (in %) [Срок оценки: within 4 weeks from operation]
• Rate of parathyroid auto-transplantation (in %) [Срок оценки: within operation]
• Day 0 PTH [Срок оценки: Post-operative Day 0]
• Day 1 Post-operative serum parathyroid hormone levels (pmol/L) [Срок оценки: Post-operative Day 1]
• 3-month Post-operative serum parathyroid hormone levels (pmol/L) [Срок оценки: Post-operative 3 months]
• 6-month Post-operative serum parathyroid hormone levels (pmol/L) [Срок оценки: Post-operative 6 months]

Критерии участия

Критерии включения

• Adult patients ≥18 years of age
• Undergoing total thyroidectomy, or completion total thyroidectomy
• Pre-operative serum adjusted calcium levels within normal ranges

Критерии исключения

• Patients on pre-operative calcium or vitamin D supplements
• Patients with pre-operative vitamin D deficiency, defined as serum vitamin D<30nmol/L
• Patients with untreated primary or secondary hyperparathyroidism
• Patient with known non-surgical hypoparathyroidism diseases
• Patients with estimated glomerular filtration rate <30ml/1.73m2/min, on dialysis, or having a history of kidney transplant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Публикации

• Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15:
• Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14:
• Lui DTW, Fung MMH, Lee CH, Fong CHY, Woo YC, Lang BHH. A territory-wide assessment of the incidence of persistent hypoparathyroidism after elective thyroid surgery and its impact on new fracture risk over time. Surgery. 2021 Nov;170(5):1369-1375. doi: 10.1016/j.surg.2021.05.004. Epub 2021 Jun 8. PMID 34116859
• Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. PMID 24402815
• Payne RB, Little AJ, Williams RB, Milner JR. Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J. 1973 Dec 15;4(5893):643-6. doi: 10.1136/bmj.4.5893.643. PMID 4758544
• Solorzano CC, Thomas G, Baregamian N, Mahadevan-Jansen A. Detecting the Near Infrared Autofluorescence of the Human Parathyroid: Hype or Opportunity? Ann Surg. 2020 Dec;272(6):973-985. doi: 10.1097/SLA.0000000000003700. PMID 31804401
• Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6. PMID 29122325
• Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31. PMID 30710614

Идентификаторы

NCT: NCT07416149 · UW-25-412

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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