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

This study is currently recruiting participants.
Verified September 2016 by Gaosong Wu, Tongji Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906748
First Posted: September 20, 2016
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gaosong Wu, Tongji Hospital
  Purpose
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.

Condition Intervention
Parathyroid Autologous Transplantation 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Resource links provided by NLM:


Further study details as provided by Gaosong Wu, Tongji Hospital:

Primary Outcome Measures:
  • parahthyroid hormone gradient by comparing between grafted and non-grafted forearm [ Time Frame: 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:
  • hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml) [ Time Frame: 6 months ]

Estimated Enrollment: 280
Study Start Date: April 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: new site for parathyroid auto-graft
choose the site fairly close to the antecubital vein for parathyroid auto-transplantation
Procedure: injection with a syringe in new-site for parathyroid autografting
new-site for parathyroid autografting, close to the antecubital vein
Other Names:
  • parathyroid autotransplantation
  • parathyroid auto-implantation
  • parathyroid auto-graft
Active Comparator: traditional parathyroid autograft
choose not intensely close to antecubital vein for parathyroid auto-transplantation
Procedure: injection with a syringe in traditional site for parathyroid autografting
traditional-site for parathyroid autografting,not intensively close to the antecubital vein

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with indications for PA treatment during cervical surgery

Exclusion Criteria:

  • patients suffering secondary hypoparathyroidism with forearm fistulization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906748


Contacts
Contact: Gaosong Wu, PhD 0086-138-7144-4606 wugaosongtj@163.com

Locations
China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Gaosong Wu, PhD    0086-138-7144-4606    wugaosongtj@163.com   
Sponsors and Collaborators
Tongji Hospital
Investigators
Study Director: Gaosong Wu, PhD Department of Thyroid and Breast Surgery Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  More Information

Responsible Party: Gaosong Wu, Doctor, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02906748     History of Changes
Other Study ID Numbers: PA in Tongji Hospital
First Submitted: September 12, 2016
First Posted: September 20, 2016
Last Update Posted: October 16, 2017
Last Verified: September 2016

Keywords provided by Gaosong Wu, Tongji Hospital:
parathyroid autografting
thyroidectomy
survival rate
hypoparathyroidism