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

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ClinicalTrials.gov Identifier: NCT02906748
Recruitment Status : Unknown
Verified September 2016 by Gaosong Wu, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Gaosong Wu, Tongji Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
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
Study Start Date : April 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
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
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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
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Contact: Gaosong Wu, PhD 0086-138-7144-4606 wugaosongtj@163.com

Locations
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gaosong Wu, Doctor, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02906748    
Other Study ID Numbers: PA in Tongji Hospital
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Keywords provided by Gaosong Wu, Tongji Hospital:
parathyroid autografting
thyroidectomy
survival rate
hypoparathyroidism
Additional relevant MeSH terms:
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Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs