Parathyroid Allo-transplantation With a New Technique

Not Applicable

Completed

• Conditions: Parathyroid Allo-transplantation
• Interventions: Biological: Parathyroid allo-transplantation

• Registration Number: NCT02134483
• Lead Sponsor: Erhan Aysan

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

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Primary Completion: 2015-05-01
• Study Completion: 2015-12-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parathyroid allo-transplantation	Parathyroid allo-transplantation	patients who have permanent hypoparatyroidism

Primary Outcome Measures

Name	Time	Method
to mesure patient's blood calcium	up to three months

Secondary Outcome Measures

Name	Time	Method
to mesure patient's parathormon levels	up to three months

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey