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Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery

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ClinicalTrials.gov Identifier: NCT03514251
Recruitment Status : Unknown
Verified April 2018 by Bo Wang,MD, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Wang,MD, Fujian Medical University

Study Description
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Brief Summary:
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery

Condition or disease Intervention/treatment Phase
Thyroid Cancer Hypoparathyroidism Marker; Structural Complication of Surgical Procedure Parathyroid Function Low Adverse Event Procedure: The suture marks the location of the parathyroid gland Not Applicable

Detailed 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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Routine thyroidectomy and central lymph node dissection
Experimental: Parathyroid marker group
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. The stitch marking operation time [ Time Frame: During surgery ]
    The time required for making a parathyroid marker by a suture method

  2. Specimen inspection time [ Time Frame: During surgery ]
    The time required for finding parathyroid glands in surgical specimens

  3. The number of transplanted parathyroid glands [ Time Frame: When the surgery is completed ]
    The number of parathyroid glands required for autotransplantation of parathyroid glands

  4. Parathyroid hormone level testing [ Time Frame: 0 days, 1 day, 2 weeks after surgery ]
    Parathyroid hormone levels before and after surgery

  5. Calcium levels [ Time Frame: 0 days, 1 day, 2 weeks after surgery ]
    Calcium level before and after surgery to detect


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514251


Locations
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China, Fujian
Fujian Medical University Union Hospital Recruiting
FuZhou, Fujian, China, 350001
Contact: bo wang, md    13705947900    wangbo@fjmu.edu.cn   
Sponsors and Collaborators
Bo Wang,MD
More Information
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Responsible Party: Bo Wang,MD, Clinical Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03514251    
Other Study ID Numbers: PT Marker
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bo Wang,MD, Fujian Medical University:
Thyroid Cancer
Hypoparathyroidism
parathyroid marker
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Hypoparathyroidism
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Parathyroid Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs