Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

NCT03514251 | Unknown DMC

• 1 other identifier: PT Marker
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Thyroid Cancer; Hypoparathyroidism; parathyroid marker

Outcome Measures

Primary Outcomes (5)

• The stitch marking operation time

  The time required for making a parathyroid marker by a suture method

  During surgery

• Specimen inspection time

  The time required for finding parathyroid glands in surgical specimens

  During surgery

• The number of transplanted parathyroid glands

  The number of parathyroid glands required for autotransplantation of parathyroid glands

  When the surgery is completed

• Parathyroid hormone level testing

  Parathyroid hormone levels before and after surgery

  0 days, 1 day, 2 weeks after surgery

• Calcium levels

  Calcium level before and after surgery to detect

  0 days, 1 day, 2 weeks after surgery

Study Arms (2)

Control group

NO INTERVENTION

Routine thyroidectomy and central lymph node dissection

Parathyroid marker group

EXPERIMENTAL

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.

Procedure: The suture marks the location of the parathyroid gland

Interventions

The suture marks the location of the parathyroid gland PROCEDURE

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.

Parathyroid marker group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with thyroid cancer who need central compartment dissection
• Routine neck incision surgery
• Patients undergoing primary neck surgery

You may not qualify if:

• Benign thyroid tumor patients
• Selecting patients with endoscopes, small incisions, or robotic surgery
• Patients with hyperparathyroidism

Sponsors & Collaborators

• Bo Wang,MD: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Hypoparathyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Parathyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: April 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)