The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

Thyroidectomy Clinical Trial

Official title:

The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03434067
• Other study ID #: PTH test paper
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperthyroidism
• Immunochromatographic
• PTH
• Thyroidectomy

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