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

NCT ID: NCT02906748

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Parathyroid Autologous Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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new site for parathyroid auto-graft

choose the site fairly close to the antecubital vein for parathyroid auto-transplantation

Group Type EXPERIMENTAL

injection with a syringe in new-site for parathyroid autografting

Intervention Type PROCEDURE

new-site for parathyroid autografting, close to the antecubital vein

traditional parathyroid autograft

choose not intensely close to antecubital vein for parathyroid auto-transplantation

Group Type ACTIVE_COMPARATOR

injection with a syringe in traditional site for parathyroid autografting

Intervention Type PROCEDURE

traditional-site for parathyroid autografting,not intensively close to the antecubital vein

Interventions

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injection with a syringe in new-site for parathyroid autografting

new-site for parathyroid autografting, close to the antecubital vein

Intervention Type PROCEDURE

injection with a syringe in traditional site for parathyroid autografting

traditional-site for parathyroid autografting,not intensively close to the antecubital vein

Intervention Type PROCEDURE

Other Intervention Names

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parathyroid autotransplantation parathyroid auto-implantation parathyroid auto-graft

Eligibility Criteria

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Inclusion Criteria

* patients with indications for PA treatment during cervical surgery

Exclusion Criteria

* patients suffering secondary hypoparathyroidism with forearm fistulization
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gaosong Wu

Doctor, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaosong Wu, PhD

Role: STUDY_DIRECTOR

Department of Thyroid and Breast Surgery Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gaosong Wu, PhD

Role: CONTACT

0086-138-7144-4606

Facility Contacts

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Gaosong Wu, PhD

Role: primary

0086-138-7144-4606

References

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Cui Q, Kong D, Li Z, Wang K, Zhang D, Tang J, Liao X, Yuan Q, Gong Y, Wu G. Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial. Trials. 2019 Jan 31;20(1):96. doi: 10.1186/s13063-019-3195-9.

Reference Type DERIVED
PMID: 30704522 (View on PubMed)

Other Identifiers

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PA in Tongji Hospital

Identifier Type: -

Identifier Source: org_study_id

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