Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy

Intraoperative Parathyroid Scores System Clinical Trial

— IPSS  

Official title:

Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172312
• Other study ID #: IPSSforZHAO
• Status: Completed
• Phase: N/A
• First received: May 29, 2017
• Last updated: May 31, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.

Description:

IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

1. postoperative pathology confirmed as thyroid papillary carcinoma;

2. for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;

3. preoperative serum calcium, parathyroid hormone levels were normal;

4. intraoperative and postoperative clinical data integrity, standardized follow-up patients;

5. parathyroid is a tumor violation.

Exclusion Criteria:

1. serious underlying disease;

2. age greater than 60 years of age or combined with arteriosclerotic disease;

3. patients with postoperative loss;

4. patients with parathyroid disease.

Related Conditions & MeSH terms

• Intraoperative Parathyroid Scores System

Intervention

Procedure:
• Different range of thyroid surgery
Observe and record parathyroid status during thyroid surgery

Locations

Country	Name	City	State
China	Wen-xin ZHAO	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transplantation Parathyroid Scores correlated with transplanted parathyroid function	relation with transplantation Parathyroid Scores and transplanted parathyroid hormone	2014-2016
Primary	the value of IPSS and in situ Parathyroid Scores	relation with Intraoperative Parathyroid Scores and in situ Parathyroid Scores	2014-2016
Primary	predicted function of IPSS	IPSS and in suit PSS be recoded and D1,D14 PTH Ca2+ were tested	2014-2016
Primary	value of IPSS in low PTH patients	IPSS and in suit PSS be recoded and D1,D14 PTH Ca2+ were tested	2014-2016
Secondary	value of IPSS for Surgeon and patient	description the clinic value	2014-2016