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Evaluation of Central Compartment Dissection Without Thyroidectomy

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ClinicalTrials.gov Identifier: NCT03454464
Recruitment Status : Unknown
Verified September 2018 by Bo Wang,MD, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : March 6, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bo Wang,MD, Fujian Medical University

Brief Summary:
In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.To evaluate the practicable, thoroughness and Clinical value of bilateral central compartment dissection while preserve contrary thyroid glands.

Condition or disease Intervention/treatment Phase
Thyroidectomy Thyroid Cancer Central Compartment Neck Dissction Procedure: Conventional Procedure: central neck dissection first Not Applicable

Detailed Description:
In accordance with the current guidelines,papillary thyroid microcarcinoma such as turmo invasive nerve or trachea, requires total thyroidectomy for follow-up iodine-131 treatment.In the course of clinical work, if the patient can achieve R0 resection, most of the patients do not need iodine-131 treatment,Therefore, there is no need to continue total thyroidectomy.This study assesses new procedures by adjusting the sequence of procedures. complications and the thoroughness of the operation were evaluated, thus Clinical value of bilateral central compartment dissection with preserve contrary thyroid glands were ananlyed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Evaluate the Practicable, Thoroughness and Clinical Value of Bilateral Central Compartment Dissection While Preserve Contrary Thyroid Glands
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Sham Comparator: Conventional operation group
Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.
Procedure: Conventional
Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure

Experimental: central neck dissection first group
central neck dissection first group,after FNA confirmed of thyroid carcinoma, the central compartment neck dissection was carried out before thyroidectomy , finally complement of central compartment neck dissection.
Procedure: central neck dissection first
central neck dissection first ,after FNA confirmed of thyroid carcinoma, the central compartment neck dissection was carried out before thyroidectomy , finally complement of central compartment neck dissection.




Primary Outcome Measures :
  1. number of the lymph node [ Time Frame: 2 day post operation ]
    the number of the lymph node

  2. number of postive lymph node [ Time Frame: 2 day post operation ]
    The number of postive lymph node

  3. The weight of the central compartment tissue. [ Time Frame: introoperation ]
    The weight of the central compartment tissue.


Secondary Outcome Measures :
  1. thyroid volume [ Time Frame: The day before the operation ]
    thyroid volume

  2. recurrent laryngeal nerve palsy [ Time Frame: 1 day ,2weeks,3months,6months post operation ]
    the number of recurrent laryngeal nerve palsy



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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:

Tumor diameter less than 1cm The tumor is located in the lower part of the gland No lateral cervical lymph node metastases Traditional open surgery

Exclusion Criteria:

Select the endoscopic surgery or robotic surgery patients Tumor invades the surrounding trachea and esophagus Patients refused to participate


Information from the National Library of Medicine

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): NCT03454464


Contacts
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Contact: wen-xin zhao, md 13365910359 zhaowx@fjmu.edu.cn
Contact: bo wang, md 13705947900 wangbo@fjmu.edu.cn

Locations
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China, Fujian
Wen-xin ZHAO Recruiting
Fuzhou, Fujian, China, 350001
Contact: Wen-xin ZHAO, MD    8613365910359    zhaowx@fjmu.edu.cn   
Contact: Bo WANG, MD    8613705947900    wangbo@fjmu.edu.cn   
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Director: wen-xin zhao, md fujian meidcal university
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Responsible Party: Bo Wang,MD, Clinical professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT03454464    
Other Study ID Numbers: CCD
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms