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Status unknownNCT03434067Updated Sep 18, 2018

The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

An observational study in Hyperthyroidism, Thyroidectomy and PTH, sponsored by Bo Wang,MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Bo Wang,MD · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperthyroidism
  • Thyroidectomy
  • PTH
  • Immunochromatographic

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Keywords

  • hyperthyroidism
  • thyroidectomy
  • PTH
  • immunochromatographic assay
03

In context

Hyperthyroidism

112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.

This study's planned enrollment of 90 is close to the median of 98 across 48 observational studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Bo Wang,MD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We use the characteristics of short half-life of the parathyroid hormone and try to evaluate it by PTH strip semi-quantitative method. PTH, blood calcium and PTH test were measured at pre-operation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. To evaluate the reliability and accuracy of PTH strip in evaluating the Miami principles with the linear relation of blood PTH and the test paper method.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary hyperthyroidism.
  • Secondary hyperthyroidism
  • Unilateral thyroidectomy.
  • Total thyroidectomy and bilateral central compartment dissection

Exclusion criteria

Exclusion Criteria:

  • age Older than 70 or younger than 18.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Serum PTH

    Routine serum PTH test, using immunoluminescence.

    Time frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

  2. Serum calcium

    Routine serum electrolyte detection.

    Time frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

  3. PTH test paper

    PTH test paper test for blood

    Time frame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

07

Study locations

1 of 1 sites recruiting
  • Wen-xin ZHAO
    Fuzhou, Fujian 350001, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03434067
Lead sponsor
Bo Wang,MD
Responsible party
Bo Wang,MD (Clinical professor, Fujian Medical University) — Sponsor-investigator
First posted
Feb 15, 2018
Start date
Jan 1, 2018
Primary completion
Jun 30, 2018
Completion
Dec 30, 2018 (estimated)
Last update
Sep 18, 2018

Study contacts

wenxin zhao, md
Contact
zhaowx@fjmu.edu.cn
13365910359
bo wang, md
Contact
wangbo@fjmu.edu.cn
13705947900
wen-xin zhao, md
study chair · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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