跳至主要内容
临床试验/NCT02134483
NCT02134483已完成不适用

Parathyroid Allo-transplantation With a New Technique

Erhan Aysan2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7
试验地点
2
主要终点
to mesure patient's blood calcium

研究概览

简要总结

Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.

详细描述

Hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . Direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. Temporary hypoparathyroidism (<6 months) develops at 10% of cases after thyroid surgery and nearly half of them develops permanent hypoparathyroidism (>6 months) (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism.

As a current standard treatment, oral or intravenous calcium preparations and active vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no beneficial effect on metabolic problems due to PH.

For these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative. Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. Various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. Despite these treatment options, convincing results have not yet been achieved . In literature, PA-t cases are often presented as case reports, only a few clinical series are available .

In this study, we aimed to present the results of our new PA-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who have permanent hypocalcemia
  • Patients who accept to participate to study

排除标准

  • Patients who don't accept to participate to study

结局指标

主要结局

to mesure patient's blood calcium

时间窗: up to three months

次要结局

  • to mesure patient's parathormon levels(up to three months)

研究者

发起方
Erhan Aysan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erhan Aysan

Bezmialem Vakif University

SB Istanbul Education and Research Hospital

研究点 (2)

Loading locations...

相似试验