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

T

Tongji Hospital

Status

Unknown

Conditions

Parathyroid Autologous Transplantation

Treatments

Procedure: injection with a syringe in new-site for parathyroid autografting
Procedure: injection with a syringe in traditional site for parathyroid autografting

Study type

Interventional

Funder types

Other

Identifiers

NCT02906748
PA in Tongji Hospital

Details and patient eligibility

About

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.

Enrollment

280 estimated patients

Sex

All

Ages

10 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with indications for PA treatment during cervical surgery

Exclusion criteria

  • patients suffering secondary hypoparathyroidism with forearm fistulization

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

280 participants in 2 patient groups

new site for parathyroid auto-graft
Experimental group
Description:
choose the site fairly close to the antecubital vein for parathyroid auto-transplantation
Treatment:
Procedure: injection with a syringe in new-site for parathyroid autografting
traditional parathyroid autograft
Active Comparator group
Description:
choose not intensely close to antecubital vein for parathyroid auto-transplantation
Treatment:
Procedure: injection with a syringe in traditional site for parathyroid autografting

Trial contacts and locations

1

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Central trial contact

Gaosong Wu, PhD

Data sourced from clinicaltrials.gov

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