The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

NCT ID: NCT03434067

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-12-30

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.

Conditions

Hyperthyroidism; Thyroidectomy; PTH; Immunochromatographic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Unilateral thyroidectomy

Patients diagnosed with unilateral thyroid benign tumor were prepared for unilateral thyroidectomy. PTH test paper is used addtional at postoperation

No interventions assigned to this group

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bo Wang,MD

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

wen-xin zhao, md

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Wen-xin ZHAO

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

wenxin zhao, md

Role: CONTACT

zhaowx@fjmu.edu.cn

13365910359

bo wang, md

Role: CONTACT

wangbo@fjmu.edu.cn

13705947900

Facility Contacts

Wen-xin ZHAO, MD

Role: primary

zhaowx@fjmu.edu.cn

8613365910359

Bo WANG, MD

Role: backup

wangbo@fjmu.edu.cn

8613705947900

Other Identifiers

PTH test paper

Identifier Type: -

Identifier Source: org_study_id