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

September 14, 2016 updated by: Gaosong Wu, Tongji Hospital

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with indications for PA treatment during cervical surgery

Exclusion Criteria:

  • patients suffering secondary hypoparathyroidism with forearm fistulization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

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
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
1 months, 3 months and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA in Tongji Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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