Back to resultsEvaluation of Central Compartment Dissection Without Thyroidectomy
Primary Purpose
Thyroidectomy, Thyroid Cancer, Central Compartment Neck Dissction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional
central neck dissection first
Sponsored by
About this trial
This is an interventional treatment trial for Thyroidectomy
Eligibility 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
Sites / Locations
- Wen-xin ZHAORecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Conventional operation group
central neck dissection first group
Arm Description
Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.
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.
Outcomes
Primary Outcome Measures
number of the lymph node
the number of the lymph node
number of postive lymph node
The number of postive lymph node
The weight of the central compartment tissue.
The weight of the central compartment tissue.
Secondary Outcome Measures
thyroid volume
thyroid volume
recurrent laryngeal nerve palsy
the number of recurrent laryngeal nerve palsy
Full Information
NCT ID
NCT03454464
First Posted
February 7, 2018
Last Updated
September 17, 2018
Sponsor
Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03454464
Brief Title
Evaluation of Central Compartment Dissection Without Thyroidectomy
Official Title
To Evaluate the Practicable, Thoroughness and Clinical Value of Bilateral Central Compartment Dissection While Preserve Contrary Thyroid Glands
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Thyroid Cancer, Central Compartment Neck Dissction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional operation group
Arm Type
Sham Comparator
Arm Description
Conventional operation group,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure.
Arm Title
central neck dissection first group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional
Intervention Description
Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure
Intervention Type
Procedure
Intervention Name(s)
central neck dissection first
Intervention Description
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 Measure Information:
Title
number of the lymph node
Description
the number of the lymph node
Time Frame
2 day post operation
Title
number of postive lymph node
Description
The number of postive lymph node
Time Frame
2 day post operation
Title
The weight of the central compartment tissue.
Description
The weight of the central compartment tissue.
Time Frame
introoperation
Secondary Outcome Measure Information:
Title
thyroid volume
Description
thyroid volume
Time Frame
The day before the operation
Title
recurrent laryngeal nerve palsy
Description
the number of recurrent laryngeal nerve palsy
Time Frame
1 day ,2weeks,3months,6months post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wen-xin zhao, md
Phone
13365910359
Email
zhaowx@fjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wen-xin zhao, md
Organizational Affiliation
fujian meidcal university
Official's Role
Study Director
Facility Information:
Facility Name
Wen-xin ZHAO
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-xin ZHAO, MD
Phone
8613365910359
Email
zhaowx@fjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Bo WANG, MD
Phone
8613705947900
Email
wangbo@fjmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Central Compartment Dissection Without Thyroidectomy
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