Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy (IPSS)

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

Study Overview

• Status: Completed
• Conditions: Intraoperative Parathyroid Scores System
• Intervention / Treatment: Procedure: Different range of thyroid surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Wen-xin ZHAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who need thyroid surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total thyroidectomy; Patients need to do total thyroidectomy According to guidelines	Procedure: Different range of thyroid surgery; Observe and record parathyroid status during thyroid surgery
Hemithyroidectomy; Patients need to do Hemithyroidectomy According to guidelines	Procedure: Different range of thyroid surgery; Observe and record parathyroid status during thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transplantation Parathyroid Scores correlated with transplanted parathyroid function	relation with transplantation Parathyroid Scores and transplanted parathyroid hormone	2014-2016
the value of IPSS and in situ Parathyroid Scores	relation with Intraoperative Parathyroid Scores and in situ Parathyroid Scores	2014-2016
predicted function of IPSS	IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested	2014-2016
value of IPSS in low PTH patients	IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested	2014-2016

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
value of IPSS for Surgeon and patient	description the clinic value	2014-2016

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: thyroid cancer; prediction; hypoparathyroidism; total thyroidectomy; Intraoperative Parathyroid Scores System
• Other Study ID Numbers: IPSSforZHAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No