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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03434067
Other study ID # PTH test paper
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 30, 2018

Study information

Verified date September 2018
Source Fujian Medical University
Contact wenxin zhao, md
Phone 13365910359
Email zhaowx@fjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China Wen-xin ZHAO Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Bo Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum PTH Routine serum PTH test, using immunoluminescence. 0 minutes, 15 minutes, 1 hour and 24 hours post operation
Primary Serum calcium Routine serum electrolyte detection. 0 minutes, 15 minutes, 1 hour and 24 hours post operation
Primary PTH test paper PTH test paper test for blood 0 minutes, 15 minutes, 1 hour and 24 hours post operation
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