Clinical trial NCT02134483: Parathyroid Allo-transplantation With a New Technique
Official title: Parathyroid Allo-transplantation With a New Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parathyroid Allo-transplantation
Keywords: Parathyroid
Permanent hypocalcemia
Transplantation
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Patients who don't accept to participate to study

Primary outcomes:
measure: to mesure patient's blood calcium
timeFrame: up to three months
Secondary outcomes:
measure: to mesure patient's parathormon levels
timeFrame: up to three months
Other outcomes:
measure: to control patient's need for calcium containing drugs
timeFrame: up to three months
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: erhan aysan
role: PRINCIPAL_INVESTIGATOR
References: