Clinical trial NCT03434067: The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism
Official title: The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperthyroidism
Thyroidectomy
PTH
Immunochromatographic
Keywords: hyperthyroidism
thyroidectomy
PTH
immunochromatographic assay
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum PTH
timeFrame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation
measure: Serum calcium
timeFrame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation
measure: PTH test paper
timeFrame: 0 minutes, 15 minutes, 1 hour and 24 hours post operation
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Wen-xin ZHAO
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: wen-xin zhao, md
role: STUDY_CHAIR
References: