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The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

Sponsor
Bo Wang,MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03434067
Collaborator
(none)
90
Enrollment
1
Location
11.9
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid PTH test paper in operation of hyperparathyroidism.PTH test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper method.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary hyperparathyroidism is a clinically common disease. At present, the gold standard for determining whether the operation is successful is based on the Miami principle. That means The PTH hormone decreased to 30% of the baseline level after 15min after the tumor was removed. However, due to the differences in PTH monitoring conditions in various hospitals, many hospitals cannot perform rapid PTH monitoring in the operation. Therefore many doctors choose rapid freezing pathology to confirm the lesion., This also led to the inability to evaluate PTH in the presence of multiple lesions,and resulting in the need for reoperations.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Jun 30, 2018
    Anticipated Study Completion Date :
    Dec 30, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Primary hyperthyroidism

    Patients diagnosed with primary hyperparathyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle
    Secondary hyperthyroidism

    Patients diagnosed with Secondary hyperthyroidism are prepared for parathyroid surgery. PTH test paper is used addtional at the time point according to Miami principle
    Unilateral thyroidectomy

    Patients diagnosed with unilateral thyroid benign tumor were prepared for unilateral thyroidectomy. PTH test paper is used addtional at postoperation
    thyroidectomy and bilateral CCD

    Patients diagnosed with bilateral thyroid carcinoma were prepared to undergo total thyroidectomy and bilateral central clearing.PTH test paper is used addtional at postoperation

    Outcome Measures

    Primary Outcome Measures

    1. Serum PTH [0 minutes, 15 minutes, 1 hour and 24 hours post operation]

      Routine serum PTH test, using immunoluminescence.

    2. Serum calcium [0 minutes, 15 minutes, 1 hour and 24 hours post operation]

      Routine serum electrolyte detection.

    3. PTH test paper [0 minutes, 15 minutes, 1 hour and 24 hours post operation]

      PTH test paper test for blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primary hyperthyroidism.

    • Secondary hyperthyroidism

    • Unilateral thyroidectomy.

    • Total thyroidectomy and bilateral central compartment dissection

    Exclusion Criteria:
    • age Older than 70 or younger than 18.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wen-xin ZHAO Fuzhou Fujian China 350001

    Sponsors and Collaborators

    • Bo Wang,MD

    Investigators

    • Study Chair: wen-xin zhao, md, Fujian Medical University Union Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bo Wang,MD, Clinical professor, Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT03434067
    Other Study ID Numbers:
    • PTH test paper
    First Posted:
    Feb 15, 2018
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bo Wang,MD, Clinical professor, Fujian Medical University
    hyperthyroidism
    thyroidectomy
    PTH
    immunochromatographic assay
    Additional relevant MeSH terms:
    Hyperparathyroidism
    Hyperthyroidism

    Study Results

    No Results Posted as of Sep 18, 2018