Parathyroid Auto-transplantation: Prospective Randomized Trial of the Personalized Site

Study Overview
=================
Brief Summary
-----------------
The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.

Official Title
-----------------
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Conditions
-----------------
Parathyroid Autologous Transplantation

Intervention / Treatment
-----------------
* Procedure: injection with a syringe in new-site for parathyroid autografting
* Procedure: injection with a syringe in traditional site for parathyroid autografting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with indications for PA treatment during cervical surgery Exclusion Criteria: patients suffering secondary hypoparathyroidism with forearm fistulization

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new site for parathyroid auto-graft<br>choose the site fairly close to the antecubital vein for parathyroid auto-transplantation | Procedure: injection with a syringe in new-site for parathyroid autografting<br>* new-site for parathyroid autografting, close to the antecubital vein<br>* Other names: parathyroid auto-graft;|
| Active Comparator: traditional parathyroid autograft<br>choose not intensely close to antecubital vein for parathyroid auto-transplantation | Procedure: injection with a syringe in traditional site for parathyroid autografting<br>* traditional-site for parathyroid autografting,not intensively close to the antecubital vein<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parahthyroid hormone gradient by comparing between grafted and non-grafted forearm | The survival criteria is that the gradient of parathyroid hormone reaches 1.5 time or greater by comparing between grafted and non-grafted forearm | 1 months, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parathyroid autografting, thyroidectomy, survival rate, hypoparathyroidism