Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

Thyroid Cancer Clinical Trial

Official title:

Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03514251
• Other study ID #: PT Marker
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2018
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery

Description:

This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with thyroid cancer who need central compartment dissection

• Routine neck incision surgery

• Patients undergoing primary neck surgery

Exclusion Criteria:

• Benign thyroid tumor patients

• Selecting patients with endoscopes, small incisions, or robotic surgery

• Patients with hyperparathyroidism

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Hypoparathyroidism
• Marker; Structural
• Parathyroid Function Low Adverse Event
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• The suture marks the location of the parathyroid gland
When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	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	The stitch marking operation time	The time required for making a parathyroid marker by a suture method	During surgery
Primary	Specimen inspection time	The time required for finding parathyroid glands in surgical specimens	During surgery
Primary	The number of transplanted parathyroid glands	The number of parathyroid glands required for autotransplantation of parathyroid glands	When the surgery is completed
Primary	Parathyroid hormone level testing	Parathyroid hormone levels before and after surgery	0 days, 1 day, 2 weeks after surgery
Primary	Calcium levels	Calcium level before and after surgery to detect	0 days, 1 day, 2 weeks after surgery