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

Not Applicable

• Conditions: Parathyroid Autologous Transplantation
• Interventions: Procedure: injection with a syringe in traditional site for parathyroid autografting; Procedure: injection with a syringe in new-site for parathyroid autografting

• Registration Number: NCT02906748
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• patients with indications for PA treatment during cervical surgery

Exclusion Criteria

• patients suffering secondary hypoparathyroidism with forearm fistulization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional parathyroid autograft	injection with a syringe in traditional site for parathyroid autografting	choose not intensely close to antecubital vein for parathyroid auto-transplantation
new site for parathyroid auto-graft	injection with a syringe in new-site for parathyroid autografting	choose the site fairly close to the antecubital vein for parathyroid auto-transplantation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml)	6 months

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China