The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

• Conditions: Thyroidectomy; PTH; Immunochromatographic; Hyperthyroidism

• Registration Number: NCT03434067
• Lead Sponsor: Bo Wang,MD

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-27
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Primary Completion: 2018-06-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum PTH	0 minutes, 15 minutes, 1 hour and 24 hours post operation	Routine serum PTH test, using immunoluminescence.
PTH test paper	0 minutes, 15 minutes, 1 hour and 24 hours post operation	PTH test paper test for blood
Serum calcium	0 minutes, 15 minutes, 1 hour and 24 hours post operation	Routine serum electrolyte detection.

Trial Locations

Locations (1)

Wen-xin ZHAO; 🇨🇳 Fuzhou, Fujian, China