甲状旁腺在新部位进行自体移植以更好地评估移植腺体功能：一项前瞻性随机对照试验的研究方案
Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial.
作者信息
Cui Qiuxia, Kong Deguang, Li Zhihua, Wang Kun, Zhang Dan, Tang Jianing, Liao Xing, Yuan Qianqian, Gong Yan, Wu Gaosong
机构信息
Department of Thyroid and Breast Surgery, Zhongnan Hospital, Wuhan University, 169 Donghu Road, Wuhan, Hubei, 430071, China.
Department of General Surgery, Hubei Provincial Hospital of TCM, 856 Luoyu Road, Wuhan, China.
出版信息
Trials. 2019 Jan 31;20(1):96. doi: 10.1186/s13063-019-3195-9.
BACKGROUND
Hypoparathyroidism is one of the most common complications encountered in thyroidectomy. In addition to parathyroid in-situ preservation, parathyroid autotransplantation (PA) is another important remedial method for patients whose parathyroid glands have been removed. However, an accurate evaluation method for the function of a transplanted parathyroid is lacking. Our preliminary study indicated that patients with PA at novel sites near antecubital veins had higher serum concentrations of parathyroid hormone (PTH). Therefore, the main hypothesis is that a grafted site closer to the cephalic vein is more useful for better evaluation of transplanted parathyroid function. This study aims to confirm the more efficient and accurate evaluation system through a prospective, randomized controlled trial.
METHODS
In total, 280 patients will be enrolled in this study and randomly divided into two groups: 140 patients with transplanted parathyroid glands in the traditional sites (group A) and the other 140 transplanted in the novel sites (group B), close to the antecubital veins. The serum concentration of PTH and calcium ion from both forearms will be measured and monitored regularly for 12 months. The primary outcome of this trial will be the survival of grafted glands, defined as the ratio of PTH between the grafted vs. the non-grafted forearms being no less than 1.5. The secondary outcome is hypoparathyroidism, defined as the PTH level from the non-grafted forearms being less than 15 pg/ml (normal range 15-65 pg/ml).
DISCUSSION
Our results from this study should provide a more accurate method to evaluate the function of transplanted parathyroid glands by comparing PTH concentrations in both the grafted and non-grafted forearms following PA at novel sites. A better PTH measurement is helpful not only for the management of postoperative patients, but also for further identification of factors affecting PA success.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02906748 . Registered on 16 March 2016.
背景
甲状旁腺功能减退是甲状腺切除术中最常见的并发症之一。除了甲状旁腺原位保留外，甲状旁腺自体移植（PA）是甲状旁腺已被切除患者的另一种重要补救方法。然而，目前缺乏一种评估移植甲状旁腺功能的准确方法。我们的初步研究表明，在前臂静脉附近新部位进行PA的患者血清甲状旁腺激素（PTH）浓度较高。因此，主要假设是移植部位越靠近头静脉，越有助于更好地评估移植甲状旁腺的功能。本研究旨在通过一项前瞻性随机对照试验来证实更有效、准确的评估系统。
方法
本研究共纳入280例患者，随机分为两组：140例患者的甲状旁腺移植于传统部位（A组），另外140例移植于靠近前臂静脉的新部位（B组）。定期测量并监测两组患者双侧前臂的PTH血清浓度和钙离子浓度，为期12个月。本试验的主要结局是移植腺体的存活情况，定义为移植侧与未移植侧前臂的PTH比值不低于1.5。次要结局是甲状旁腺功能减退，定义为未移植侧前臂的PTH水平低于15 pg/ml（正常范围15 - 65 pg/ml）。
讨论
本研究结果应能提供一种更准确的方法，通过比较在新部位进行PA后移植侧与未移植侧前臂的PTH浓度来评估移植甲状旁腺的功能。更好地测量PTH不仅有助于术后患者的管理，还有助于进一步确定影响PA成功的因素。
试验注册
ClinicalTrials.gov，标识符：NCT02906748。于2016年3月16日注册。
Zotero 插件