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临床试验/NCT06804681
NCT06804681尚未招募不适用

Is Intraoperative PTH Monitoring Obsolete in Times of Choline PET/CT?

University of Zurich1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Determine the successful removal of all parathyroid glands responsible for the pHPT based on the preoperative Choline-PET/CT findings with measurement of parathormone and calcium level

研究概览

简要总结

In patients with primary hyperparathyreoidism (pHPT) in 80-90% only one of the four parathyroid glands has developed an autonomy and is causative for the disease. Localisation diagnostics are used to help identify the affected gland or glands in order to enable more focused surgical approaches and reduce morbidity of the surgery, as well as operative time. The gold standard for imaging in Germany and Austria are sonography and scintigraphy. If imaging is not conclusive, Choline-PET/CT, which has been shown to have a higher specificity than the scintigraphy, especially for multiglandular disease, is performed mostly in Austria, but only on special indications in Germany. In Switzerland, as of 2023 the Choline-PET/CT has replaced the scintigraphy and is routinely performed in patients with indication for parathyroidectomy in many hospitals.

The current S2k guideline recommends to perform an intraoperative PTH measurement before and 10 minutes after removal of the parathyroid gland in order to assess the success of the surgery. Due to the short half-life of PTH of around three minutes, a PTH drop of 50% or into the normal range within 10 minutes of removal of the suspected gland has a high sensitivity and specificity for cure. If PTH drop is inadequate, further gland exploration is performed. The intraoperative measurement of PTH is associated with waiting time in the OR and uncertainty if the next patient can be anesthetized, prolonging surgeries by 30-60 minutes depending on the local facilities. If the Choline-PET/CT is sufficiently sensitive and specific in detecting both uni- and multiglandular disease, surgery according to Choline-PET/CT findings could make waiting for intraoperative PTH drop unnecessary.

The aim of the study is to determine whether the regular use of Choline-PET/CT can obviate the need for intraoperative PTH-measurement with the potential to shorten the length of parathyroid surgeries. This could save considerable costs and justify the regular use of Choline-PET/CT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • pHPT, preoperative Choline-PET, intraoperative PTH

排除标准

  • no consent

结局指标

主要结局

Determine the successful removal of all parathyroid glands responsible for the pHPT based on the preoperative Choline-PET/CT findings with measurement of parathormone and calcium level

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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